Z-1533-2013 Class II Terminated
FDA device recall Z-1533-2013 was initiated by Bard Peripheral Vascular Inc on May 28, 2013 and is designated Class II. 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… The recall status is terminated (terminated Oct 23, 2013). Affected quantity: 415.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2013
- Initiation Date
- May 28, 2013
- Termination Date
- Oct 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 415
Product Description
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.
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1533-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026