Recall Z-1646-2024— Boston Scientific Corporation

Name: FDA recall Z-1646-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-21

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2024-03-21. It names one FDA 510(k) clearance: K152605. Product: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter. Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining..

Recalling firm: Boston Scientific Corporation
Classification: Class I
Status: Ongoing
Initiated: 2024-03-21
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K152605 — Impulse Angiographic Catheter, Expo Angiographic CatheterBoston Scientific Corporation·cleared 2015-10-29

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

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

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