PFM Medical recalls two Multi-Snare Set models due to potential biocompatibility issues that could cause tissue irritation if used in vascular procedures.
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
PFM Medical is recalling two specific Multi-Snare Set models because they may cause tissue irritation or inflammation if used in vascular procedures. This is a safety concern for medical professionals using these devices during procedures.
The snare catheters in these sets failed biocompatibility tests, meaning they could cause inflammation and tissue irritation if they come into contact with a patient's blood vessels during vascular procedures.
Medical professionals using the recalled Multi-Snare Sets for vascular procedures are most at risk. Patients receiving these procedures may also be affected if the device causes irritation.
Check for the product model: 5 mm x 125 cm (REF: 147305) or 10 mm x 125 cm (REF: 147310). These were sold with specific expiration dates and lot numbers.
Look for the reference numbers 147305 or 147310 on the product packaging or label.
The Multi-Snare Sets failed biocompatibility tests and could cause tissue irritation if used in vascular procedures.
The recall record does not specify a remedy or action steps for affected users.
The recall states potential tissue irritation but does not mention serious injury risks.
We’ve drafted a message you can send PFM Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2526-2026 — PFM Medical PFM Medical Hello, I own a PFM Medical that is covered by recall Z-2526-2026 from PFM 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
