Z-1533-2013Class II

BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm

Name: Z-1533-2013 BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm
Creator: Bard Peripheral Vascular Inc
Published: 2013-05-28
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2013-05-28 / Terminated / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended... on 2013-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1533-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-06-12
Terminated: 2013-10-23
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: DQY Catheter, Percutaneous
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: 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.
Quantity in commerce: 415
Distribution: US Nationwide Distribution
Product codes and lots: Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1533-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1533-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12

Product code DQY

K073472Class IIVaccess Pta Balloon Dilatation CatheterC.R. Bard, Inc. / cleared 2008-01-09

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)