AVID Medical recalls Halyard PACEMAKER DRA: Model VAST020-06 with potential metal flakes causing surgical site reactions. Affected units sold with specific lot numbers.
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
AVID Medical is recalling Halyard PACEMAKER DRAPE medical convenience kits (Model VAST020-06) because small metal flakes could detach and enter surgical sites, causing reactions. This poses a risk to patients during medical procedures.
The sponge forceps and towel clamps in the kit can release small metal flakes that may enter a patient's surgical site without detection. This could lead to local reactions or foreign body reactions, which are medical complications.
Patients using these medical convenience kits during surgery are at risk. Healthcare providers who use the product for surgical site management may also be affected.
Check for the model number VAST020-06 on the product. Affected units were sold with lot numbers 1588570 or 1596857.
Look for model number VAST020-06 and lot numbers 1588570 or 1596857 on the product.
Yes, metal flakes could enter surgical sites causing reactions, so affected units should be checked.
Check for model number VAST020-06 and lot numbers 1588570 or 1596857.
The recall does not specify a remedy, so contact AVID Medical for guidance.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0443-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0443-2025 from AVID Medical. 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.
