Recall Z-1413-2015— Bard Peripheral Vascular Inc

Name: FDA recall Z-1413-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-23

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2015-03-23, terminated 2015-08-28. It names one FDA 510(k) clearance: K083657. Product: Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.. Reason: Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Terminated: 2015-08-28
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K083657 — CONQUEST PTA BALLOON DILATATION CATHETERC.R. Bard, Inc.·cleared 2008-12-24

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

Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

Reason for recall

Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.

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