—#135055

Product

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

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K083657
Affected lot / code info: Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Ste 109, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-03-23
Posted by FDA: 2015-04-10
Terminated: 2015-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.