Recall Z-1618-2018— Boston Scientific Corporation

Name: FDA recall Z-1618-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-12

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-02-12, terminated 2020-04-10. It names one FDA 510(k) clearance: K932553. Product: Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.. Reason: Potential for Capio sutures to break and /or detach..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Terminated: 2020-04-10
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K932553 — DISPOSABLE SUTURE PLACEMENT SYSTEMLaurus Medical Corp.·cleared 1994-05-12

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

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Reason for recall

Potential for Capio sutures to break and /or detach.

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