Angiodynamics recalls DURAMAX Stacked Tip kits with possible metal shavings that could cause embolism requiring surgery. Affected lots include 5807194, 580961: 5809462.
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 DURAMAX Stacked Tip kits 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 loose metal shavings that can enter the bloodstream. If these shavings travel to critical areas, they could cause blockages requiring surgery.
Hemodialysis and apheresis patients using the DURAMAX Stacked Tip kits are most at risk. The recall affects specific lot numbers of the kits.
Check the product label for lot numbers 5807194, 5809616, or 5809462. The kits are intended for long-term vascular access in hemodialysis and apheresis treatments.
Immediately stop using the DURAMAX Stacked Tip kit if it has the affected lot numbers.
The Tri-Ball Tunneler may contain loosely affixed metal shavings that could embolize and require surgical removal.
Lot numbers 5807194, 5809616, and 5809462.
The recall record does not specify a remedy.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1767-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1767-2024 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.