AVID Medical recalls Halyard Pacemaker Instrument Pack Model VAPX040-01 due to 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 its Halyard Pacemaker Instrument Pack (Model VAP:040-01) because small metal flakes could detach and enter surgical sites, causing reactions or foreign body issues. This poses a risk to patients during medical procedures.
The instrument pack contains components that can release small metal flakes during use. These flakes might enter a patient's surgical site without detection, leading to local reactions or foreign body reactions.
Patients undergoing surgery who use this pacemaker instrument pack are at risk. Medical professionals using the pack for procedures may also be affected.
Check for the model number VAPX040-01 on the instrument pack. Units sold with lot number 1590849 are affected. The pack has a GTIN of 10809160360798.
Look for model number VAPX040-01 and lot number 1590849 on the instrument pack.
Yes, metal flakes could enter surgical sites causing reactions or foreign body issues.
Check the model number and lot number; if affected, contact AVID Medical for guidance.
The product has model number VAPX040-01 and lot number 1590849, with GTIN 10809160360798.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0442-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0442-2025 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.
