Bard Peripheral Vascular Inc: Medical Device Recall in 2020 - (Recall #: Z-0080-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 1, 2020

Date Posted: October 14, 2020

Recall Number: Z-0080-2021

Event ID: 86510

Reason for Recall:

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.

Status: Terminated

Product Quantity: 281 units

Code Information:

Lot No. REDU2646 Expiration Date: 06/30/2022

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of GA, AZ, MD, CA, VA, AR, TX, SD, NC, MO, WI, CO, FL, PA and the country of Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated