Bard Vaccess PTA Balloon Catheters Recalled for Incorrect Diameter Labeling
Bard Peripheral Vascular is recalling Vaccess PTA Balloon Dilatation Catheters because the inflation hub may display an incorrect balloon diameter.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error regarding balloon diameter without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Bard Peripheral Vascular (BPV) is recalling specific lots of Vaccess PTA Balloon Dilatation Catheters. The recall addresses a labeling discrepancy where the balloon size printed on the inflation hub may read 7mm x 4cm, while the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.
The affected devices are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries, as well as for the treatment of obstructive lesions in arteriovenous dialysis fistulae. The devices are supplied sterile and intended for single use. The recall covers 415 units distributed nationwide in the US.
Healthcare providers and facilities should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already received treatment with these devices should contact their healthcare provider if they have concerns regarding the labeling discrepancy.
The recalled product
- 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 ob
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 415
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Codes and Lot Numbers
- respectively: VA8084R
- 93JW0056 VA8084
- 937W0090
Distribution
Distributed nationwide across the United States.
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