—#118770

Product

BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K073472
Affected lot / code info: Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090

Why it was recalled

Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

BARD sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated May 30, 2013 via FedEx overnight with proof of delivery notice to all affected customers. The letter identified the affected product, reason for recall, actions to be taken, and contact information. Customers were instructed to complete the enclosed Recall and Effectivenss Check Form and fax to the attention of Recall Coordinator in Customer Service at 1-800-994-6772.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2013-06-12
Terminated: 2013-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118770. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.