Recall Z-1582-2022— Boston Scientific Corporation

Name: FDA recall Z-1582-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-09

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2022-08-09. It names 2 FDA 510(k) clearances: K010853, K980453. Product: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440. Reason: The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-08-09
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K010853 — GUIDER SOFTIP GUIDING CATHETER XF 5FBoston Scientific, Target·cleared 2001-04-18
K980453 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSBoston Scientific Scimed, Inc.·cleared 1998-08-11

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 Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

Reason for recall

The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

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