Angiodynamics recalls DURAMAX VASC-PAK catheters due to potential metal shavings that could cause embolism requiring surgery. Affected units sold with lot number 5807208.
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Angiodynamics is recalling DURAM:MAX VASC-PAK vascular catheters that may contain metal shavings. These shavings could travel to the bloodstream and require surgical removal, posing a serious health risk.
The Tri-Ball Tunneler component may have loosely attached metal shavings. If these shavings enter the bloodstream, they could cause blockages or require surgical removal to prevent serious complications.
Patients receiving long-term vascular access for hemodialysis or apheresis using the recalled DURAMAX VASC-PAK catheters are affected. Those with the specific lot number 5807208 are at highest risk.
Check for the DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK catheter with product number H787103028191 and lot number 5807208. This product is used for long-term vascular access in hemodialysis treatments.
Immediately stop using the DURAMAX VASC-PAK catheter if you have the recalled lot number 5807208.
The Tri-Ball Tunneler may contain loosely affixed metal shavings that could embolize and require surgical removal.
Lot number 5807208.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1771-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1771-2024 from Angiodynamics. 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.