Z-0080-2021Class II

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

Name: Z-0080-2021 Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 -
Creator: Bard Peripheral Vascular Inc
Published: 2020-10-01
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2020-10-01 / Terminated / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal... on 2020-10-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0080-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-01
Posted: 2020-10-08
Terminated: 2022-05-25
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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
Quantity in commerce: 281 units
Distribution: 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.
Product codes and lots: Lot No. REDU2646 Expiration Date: 06/30/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0080-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0080-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code DQY

K083657Class IIConquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. / cleared 2008-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)