Recall Z-1336-2015— Boston Scientific Corporation

Name: FDA recall Z-1336-2015
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 2016-08-12. It names one FDA 510(k) clearance: K141335. Product: Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.. Reason: 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 in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Terminated: 2016-08-12
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

Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.

Reason for recall

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 in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth

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