Recall Z-0757-2021— Boston Scientific Corporation

Name: FDA recall Z-0757-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-16

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-11-16. It names one FDA 510(k) clearance: K974541. Product: Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570. Reason: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-11-16
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K974541 — MODIFIED URETERAL INDWELLING CATHETER/STENTBoston Scientific Corp·cleared 1998-02-09

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

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Reason for recall

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

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