medical Class II Updated 2020-10-14

Bard Peripheral Vascular Inc recalls Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75

Recalled Product

Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: 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.


Hazard / Issue

Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot No. REDU2646 Expiration Date: 06/30/2022
View official government recall

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