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U.S. Department of Health and Human Services

Class 2 Device Recall Conquest PTA Balloon Dilatation Catheter

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  Class 2 Device Recall Conquest PTA Balloon Dilatation Catheter see related information
Date Initiated by Firm October 01, 2020
Create Date October 08, 2020
Recall Status1 Open3, Classified
Recall Number Z-0080-2021
Recall Event ID 86510
510(K)Number K083657  
Product Classification Catheter, percutaneous - Product Code DQY
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.
Code Information Lot No. REDU2646  Expiration Date: 06/30/2022
Recalling Firm/
Manufacturer
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact BD Customer Support
888-237-2762
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = C.R. BARD, INC.
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