510(k) · Cleared

Recalled · Class I · 2019

6F Z4 Guide Catheter

K042489510(k) SpecialCleared Dec 13, 200490-day reviewClass II21 CFR 870.1250Recalls 191 (191 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · DQY Catheter, Percutaneous

Cleared on Dec 13, 2004 as substantially equivalent to K021256 (Medtronic Vascular, 2002) after a 90-day review. Its family tree reaches back 2 generations to 1998. 3 of the 12 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 191 times, including 191 Class I recalls.

Decided: Dec 13, 2004
Review: 90 days
Class: Class II
Product code: DQY
Recalls: 191 (191 Class I)
Predicates: 1

Its longest line of descent runs back 2 generations to K981198 (1998). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly. 3 of the 12 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
1 generation backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
This deviceK042489 6F Z4 Guide CatheterMedtronic Vascular · 2004
Descendant · cites it directly · 3 of its ownK060418 8F Sherpa NX Guide CatheterMedtronic Vascular · 2006
Descendant · 2 generations on · 2 of its ownK062420 5F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006
Descendant · cites it directly · 1 of its ownK083422 6F Taiga Guiding CatheterMedtronic Vascular · 2009 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK051846 7F Sherpa NX Guide CatheterMedtronic Vascular · 2005
Descendant · 2 generations on · 0 of its ownK232190 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide…Medtronic Vascular · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005high 2 (2006) · low 0 (2007)2026

Class I recalls in this family

K132673 5F & 6F Launcher Guide Catheter, 5F Sherpa…cites it directly · 2013
K083422 6F Taiga Guiding Cathetercites it directly · 2009

Most influential descendants

Showing 5 of 8 · See all

K0604188F Sherpa NX Guide CatheterMedtronic Vascular · 2006 · cites it directly3descendants
K0624205F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006 · 2 generations on2descendants
K0834226F Taiga Guiding CatheterMedtronic Vascular · 2009 · cites it directly1descendant
K0518467F Sherpa NX Guide CatheterMedtronic Vascular · 2005 · cites it directly1descendant
K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterMedtronic Vascular · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K981198	Medtronic Zuma Guiding Catheter	Medtronics Interventional Vascular	1998	25
−1	K021256	Z3 Guide Catheter	Medtronic Vascular	2002	52
0 (this device)	K042489	6F Z4 Guide Catheter	Medtronic Vascular	2004	—
+1	K060418	8F Sherpa NX Guide Catheter	Medtronic Vascular	2006	—
+2	K062420	5F Sherpa Active NX Guide Catheter	Medtronic Vascular	2006	—
+1	K083422	6F Taiga Guiding Catheter	Medtronic Vascular	2009	Class I
+1	K051846	7F Sherpa NX Guide Catheter	Medtronic Vascular	2005	—
+2	K232190	6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter	Medtronic Vascular	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2009	1	1
2013	1	1
2014	1	0
2019	1	0
2023	1	0

FIG. 1 — Lineage of K042489, 1998–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K021256	Z3 Guide Catheter Summary page 1 …6F Z4 Guiding Catheter Common Name: Percutaneous Catheter Classification Percutaneous Catheter Name: Predicate Device: 6F Launcher Guide Catheter K02 1256 Device The 6F Z4 Guide Catheter consists of a luer hub, a strain Description: relief, inner liner, a braided…	Medtronic Vascular	2002	52

Also cleared against K021256: 6 other devices →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060418	8F Sherpa NX Guide Catheter	Medtronic Vascular	2006	3
K083422	6F Taiga Guiding Catheter Class I	Medtronic Vascular	2009	1
K051846	7F Sherpa NX Guide Catheter	Medtronic Vascular	2005	1
K132673	5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding… Class I	Medtronic, Inc.	2013	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 15, 2019	Class I	Z-2657-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2632-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2748-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2587-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2594-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2665-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2661-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2576-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2742-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2679-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2716-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2655-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2642-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2569-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2714-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2577-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2584-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2704-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2629-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2751-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2603-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2703-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2595-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2690-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2695-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2667-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2578-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2746-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2648-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2621-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2701-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2693-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2645-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2698-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2743-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2708-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2729-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2562-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2623-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2620-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2619-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2653-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2669-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2618-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2624-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2641-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2640-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2702-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2734-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Class I	Z-2582-2019	Component design/selection	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

The 5 latest of 50 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K1326735F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding CatheterMedtronic, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 1191 Class I recalls
K0834226F Taiga Guiding CatheterMedtronic Vascular · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
3 of the 3 ancestors have a recall of any class.
Of its descendants, K060418 (Medtronic Vascular, 2006) has gone furthest, with 3 descendants of its own.
6 other devices also cite its predicate K021256.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The Medtronic 6F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042489: 6F Z4 Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042489

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026