510(k) · Cleared

Recalled · Class II · 2015

Expel Apd Drainage Catheter System

K141335510(k) TraditionalCleared Oct 17, 2014149-day reviewClass II21 CFR 876.5010Recalls 2

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

Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Oct 17, 2014 as substantially equivalent to K944290 (Boston Scientific Corp, 1994) and 1 other predicate after a 149-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled 2 times.

Decided: Oct 17, 2014
Review: 149 days
Class: Class II
Product code: FGE
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K944290 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK944290 Catheters, Biliary Catheters, UrologicalBoston Scientific Corp · 1994 · Recalled
This deviceK141335 Expel Apd Drainage Catheter SystemBoston Scientific Corp · 2014
Descendant · cites it directly · 0 of its ownK181669 ConvertX Biliary Stent SystemBrightwater Medical · 2019

Most influential descendants

Showing 1 of 1 · See all

K181669ConvertX Biliary Stent SystemBrightwater Medical · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944290	Catheters, Biliary Catheters, Urological	Boston Scientific Corp	1994	5
0 (this device)	K141335	Expel Apd Drainage Catheter System	Boston Scientific Corp	2014	—
+1	K181669	ConvertX Biliary Stent System	Brightwater Medical	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K141335, 1994–2019Source: 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.

Planning a device in FGE? 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 FGE device

#1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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
*	K944290	Catheters, Biliary Catheters, Urological Summary page 6 …Pg. 2 of 4 Predicate Devices Flexima™ APD™ All Purpose Drainage Catheter Set (K944290, 08-Dec-1994) Flexima™ Biliary Drainage Catheter with RO Marker (K023870, 20-Dec-2002)…	Boston Scientific Corp	1994	5
*	K023870	Flexima Biliary Catheter Summary page 6 …All Purpose Drainage Catheter Set (K944290, 08-Dec-1994) Flexima™ Biliary Drainage Catheter with RO Marker (K023870, 20-Dec-2002) Intended Use / Expel™ Drainage Catheter APD Drainage Catheter, Indications for Expel™ Drainage Catheter w…	Boston Scientific/Medi-Tech	2002	2

Also cleared against K944290: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181669	ConvertX Biliary Stent System	Brightwater Medical	2019	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 25, 2015	Class II	Z-1336-2015	Nonconforming Material/Component	Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted…
Feb 25, 2015	Class II	Z-1355-2015	Device Design	Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K181669 (Brightwater Medical, 2019) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K944290.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

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

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, 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	4	316	54	1,006
2008	11	214	93	1,465
2009	7	160	18	1,655
2010	9	81	32	1,434
2011	9	114	2	1,321
2012	8	96	4	1,183
2013	5	161	3	1,060
2014	8	156	0	1,270
2015	8	79	0	1,543
2016	4	49	0	1,453
2017	9	59	1	1,515
2018	7	215	43	1,681
2019	2	—	13	1,896
2020	4	121	1	2,182
2021	1	—	27	2,297
2022	6	101	21	1,749
2023	6	199	19	1,615
2024	6	188	1	1,948
2025	7	257	0	1,923
2026	8	153	11	—

What is it indicated for?

The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections.

The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K141335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141335: Expel Apd Drainage Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141335

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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