Recall Z-2645-2017— Boston Scientific Corporation

Name: FDA recall Z-2645-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-15

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2016-12-15, terminated 2018-04-10. It names one FDA 510(k) clearance: K121694. Product: Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN). Reason: A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-12-15
Terminated: 2018-04-10
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

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)

Reason for recall

A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

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