Z-1413-2015Class II

Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size

Name: Z-1413-2015 Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size
Creator: Bard Peripheral Vascular Inc
Published: 2015-03-23
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2015-03-23 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124 on 2015-03-23. FDA classified it as Class II and gives the reason as "Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1413-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Posted: 2015-04-10
Terminated: 2015-08-28
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bard sent an Urgent Medical Device Recall Notification letter dated March 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the product code and lot combination listed on the attachment 1 of the recall letter may be at risk of having deflation related issues. Customers are instructed to complete and return the Effectiveness Check Form. Customers with questions are instructed to call Bard Peripheral Vascular's (BPV) at (800) 321-4254 option #2 Ext 2501 (M-F 7am-4pm MST) Customers are instructed to fax the recall and effectiveness check form to BPV at (800) 994-6772.
Quantity in commerce: 2620 units
Distribution: Worldwide Distribution - US Distribution including Puerto Rico and the countries of : Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singapore, Thailand, Chile, Guam, Mexico, Malaysia and Australia.
Product codes and lots: Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1413-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1413-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-10

Product code DQY

K083657Class IIConquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. / cleared 2008-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)