Bard recalls specific 40 PTA Dilation Catheters due to incorrect balloon size labeling, which may cause injury during dialysis procedures. Affected units have a risk of non-diseased vessel dilation.
The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.
Bard is recalling two specific models of 40 PTA Dilation Catheters because the packaging lists the wrong balloon size. This could lead to the balloon inflating in non-diseased blood vessels, kidney tissue, or dialysis fistula sections, potentially causing injury that requires medical attention.
The catheter packaging incorrectly states the balloon size as 8mm X 20mm instead of 8mm X 40mm. If the user advances the balloon too far into the bloodstream, it may inflate in healthy tissue, causing injury that could require additional medical or surgical treatment.
Patients undergoing dialysis who use the recalled catheters are most at risk. Healthcare providers using these specific models for procedures may also be affected.
Check for the model numbers CQF7582 or CQF7584 on the catheter packaging. The catheters were sold with a specific expiration date of February 28, 2022.
Verify the model number on the catheter packaging to confirm if it is CQF7582 or CQF7584.
The packaging incorrectly lists the balloon size as 8mm X 20mm instead of the intended 8mm X 40mm. This risk could cause injury during dialysis procedures.
The recall record does not specify a remedy, so check the product details to confirm if it is affected and contact Bard for further instructions.
The recall states that injury may occur but specifies it requires medical intervention, not immediate life-threatening risk.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-0917-2020 — Bard Bard Hello, I own a Bard that is covered by recall Z-0917-2020 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.
