Recall Z-1355-2015— Boston Scientific Corporation

Name: FDA recall Z-1355-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-25

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2015-02-25, terminated 2017-06-30. It names one FDA 510(k) clearance: K141335. Product: Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits. Reason: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Terminated: 2017-06-30
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K141335 — EXPEL APD DRAINAGE CATHETER SYSTEMBoston Scientific Corp·cleared 2014-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.