—#183861

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K083657
Affected lot / code info: Lot No. REDU2646 Expiration Date: 06/30/2022

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

On October 1, 2020, the firm mailed consignees a "Urgent Medical Device Recall Notification" via Fed EX that informed consignees about the recall. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific Catalog and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lot in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via the following: 5. MedWatch website @ www.fda.gov/medwatch; Phone: 1-800-FDA-1088 (1-800-332-1088) or Mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

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.

Timeline

Recall initiated: 2020-10-01
Terminated: 2022-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183861. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.