Recall Z-1555-2020— Boston Scientific Corporation

Name: FDA recall Z-1555-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-11

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2020-02-11. It names one FDA 510(k) clearance: K121694. Product: Imager II 5F Angiographic Catheters, 5 units per package.. Reason: Potential for tip detachment of Imager II 5F Angiographic Catheters.

Recalling firm: Boston Scientific Corporation
Classification: Class I
Status: Ongoing
Initiated: 2020-02-11
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K121694 — IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific Corp·cleared 2012-09-14

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

Imager II 5F Angiographic Catheters, 5 units per package.

Reason for recall

Potential for tip detachment of Imager II 5F Angiographic Catheters

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