Z-1355-2015Class II

Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage...

Name: Z-1355-2015 Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage...
Creator: Boston Scientific Corporation
Published: 2015-02-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-02-25 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits on 2015-02-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1355-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Posted: 2015-03-31
Terminated: 2017-06-30
Recalling firm: Boston Scientific Corporation
Product: Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: 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 reported cases, this was performed to retrieve the device fragments.
Root cause tag: design
FDA root cause: Device Design
Action: Boston Scientific sent an Urgent Medical Device Correction - Immediate Action Required letter dated February 5, 2015. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the problem and the product involved in the recall. Advised consignees to complete and return the "Recall Removal Reply Verification Tracking Form". Your local Sales Representative can answer any questions you may have regarding this Field Correction notice. For further questions please call (763) 494- 7971.
Quantity in commerce: 289
Distribution: Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.
Product codes and lots: UPN # LOT # H7493933108200 17245003, 17416605, 17489192 H7493933108350 17245004, 17245005, 17370709, 17408756 H749393310835K1 17411333, 17493554 H7493933110200 17318047 H7493933110350 17275822, 17438003, 17494025, 17501572 H749393311035K1 17328808, 17403871, 17416578, 17459144 H7493933110400 17275824, 17416608 H7493933112350 17245006, 17259580, 17275819 H7493933114350 17275815, 17338207 with Expiration Dates between January 30, 2016 and May 8, 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1355-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1355-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-31

Product code FGE

K141335Class IIExpel Apd Drainage Catheter SystemBoston Scientific Corp / cleared 2014-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)