—#91358

Product

BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135715

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K072283
Affected lot / code info: LOT NUMBERS: 93DT0146, 93DT0175, 93IT0211, 93IT0211

Why it was recalled

The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The Bard Peripheral Vascular "URGENT MEDICAL DEVICE RECALL NOTIFICATION" with attached "RECALL AND EFFECTIVENESS CHECK FORM" was sent to the affected consignees beginning May 7, 2010 via FedEx. The recall notice informed the consignees of the reason for recall, the products affected and instructed them not to use or further distribute any affected product. The consignees were also instructed to call the firm's Recall Coordinator Silvia Carrillo at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at silvia.carrillo@crbard.com to facilitate the expedient return of the affected products. Additionally they were asked to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2010-05-04
Posted by FDA: 2010-08-02
Terminated: 2012-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.