AVID Medical recalls SAMMC-N pacemaker convenience kits with model SAMM065-10 due to potential metal flakes causing surgical site reactions. Affected units include specific lot numbers and GTIN.
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 certain pacemaker convenience kits that may have metal flakes that could enter a patient's surgical site, causing reactions or foreign body issues. This recall affects specific model numbers and lots sold to medical facilities.
Small metal flakes could detach from the kit components and enter a patient's surgical site undetected. This may cause local reactions or foreign body reactions, which are typically minor but could become serious if not addressed.
Medical facilities that purchased the Halyard SAMMC-N pacemaker convenience kits with model number SAMM065-10 are likely affected. Patients using these kits during surgery are at risk of local reactions or foreign body reactions if metal flakes enter the surgical site.
Check for the model number SAMM065-10 on the kit. Affected units include specific lot numbers: 1586050, 1586407, and 1605747, as well as the GTIN 10809160370186.
Look for the model number SAMM065-10 on the Halyard SAMMC-N pacemaker convenience kit.
Small metal flakes could detach from the components and enter a patient's surgical site, causing local reactions or foreign body reactions.
Lot numbers 1586050, 1586407, and 1605747 are affected.
The recall does not specify a stop-use instruction; affected units should be checked for the model and lot numbers.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0429-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0429-2025 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.
