PMA · Approved

Recalled · Class II · 2015

7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System

P020045PMAApproved Apr 17, 2003176-day reviewClass IIIRecalls 2

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

Medtronic Cryocath, LP · LPB Cardiac Ablation Percutaneous Catheter

Approved on Apr 17, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 176-day review. It has been recalled 2 times.

Decided: Apr 17, 2003
Review: 176 days
Class: Class III
Product code: LPB
Recalls: 2

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P020045 has 102 supplements since 2003: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2003high 14 (2014) · low 1 (2003)2026

View FIG. 1 as a table

Year	Supplements approved
2003	1
2004	5
2005	6
2006	5
2007	2
2008	1
2009	2
2010	4
2011	5
2012	5
2013	4
2014	14
2015	6
2016	8
2017	6
2018	5
2019	1
2020	2
2021	5
2022	3
2023	5
2024	5
2025	1
2026	1

FIG. 1 — Supplements to P020045, 2003–2026Source: FDA PMA database

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

Planning a device in LPB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 1, 2015	Class II	Z-2777-2015	Component design/selection	An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
Aug 4, 2006	Not classified	Z-1452-06	Other	Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside…

No ancestor or descendant has a Class I recall.

How does its category compare?

All LPB devices

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

FDA decisions per year · LPB

15in 2025

2007high 85 (2014) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPB

Too few LPB 510(k)s in any year since 2007 to give a median.

Recalls per year · LPB

6in 2017

2007high 6 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPB

1,190in 2025

2007high 1,839 (2024) · low 61 (2007)2025

MAUDE reports naming product code LPB, 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	22	—	0	61
2008	20	—	4	75
2009	31	—	2	76
2010	45	—	1	63
2011	57	—	4	102
2012	38	—	0	248
2013	63	—	0	406
2014	85	—	1	799
2015	85	—	0	1,189
2016	54	—	0	1,010
2017	46	—	6	1,115
2018	35	—	0	975
2019	30	—	0	1,124
2020	33	—	0	1,182
2021	39	—	0	1,240
2022	25	—	0	1,336
2023	22	—	0	1,500
2024	18	—	0	1,839
2025	15	—	0	1,190
2026	8	—	0	—

https://510kreport.com/device/P020045 · printed Nov 3, 2026

Cite this page

510(k) Report. “P020045: 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P020045

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026