Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters Recalled by Bard Peripheral Vascular Inc Due to Bard Peripheral Vascular (BPV) has confirmed that some...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.
Affected Products
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.
Quantity: 415
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bard Peripheral Vascular Inc
Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report