Bard recalls Conquest PTA Balloon dilation Catheter (6mm x 40mm) due to incorrect balloon size. Using a smaller balloon may prolong procedures without serious injury risk.
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.
Bard is recalling a specific type of vascular catheter because it came with a smaller balloon than labeled. Using this incorrect size could make procedures last longer but does not pose a serious injury risk.
The catheter includes a 5mm x 40mm balloon instead of the labeled 6mm x 40mm. This smaller balloon may cause procedures to take longer than intended but does not cause injury.
Patients undergoing vascular procedures like angioplasty or dialysis fistula treatment may own this catheter. Those with the specific model and lot number are most at risk.
Check for the model number CQ7564 and lot number REDU2646 on the catheter packaging. The expiration date is June 30, 2022.
Verify the model number (CQ7564) and lot number (REDU2646) on the catheter packaging.
The catheter was packaged with a 5mm x 40mm balloon instead of the labeled 6mm x 40mm size, which may prolong procedures.
No, the hazard only affects procedure duration, not safety.
Check the model number and lot number on the packaging to confirm if it's affected. No action is needed if it's not the recalled model.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-0080-2021 — Bard Bard Hello, I own a Bard that is covered by recall Z-0080-2021 from Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
