FDA-Device2026-07-01Class IIPROCESSING DEFECT
PFM Medical Multi-Snare Set recalled for biocompatibility failure risk
What this means
PFM Medical's Multi-Snare Set catheters (5 mm and 10 mm models) failed to meet biocompatibility safety standards. If used, the device material could cause localized inflammation and tissue irritation when in contact with blood vessels.
- If you have these catheters (REF 147305 or 147310), stop using them immediately.
- Contact PFM Medical or your hospital's medical device coordinator for instructions on return or disposal.
- If a patient was treated with this device and develops signs of vessel inflammation or irritation, notify their physician.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of NY, MD.
Affected count
32
Manufactured in
1916 Palomar Oaks Way, N/A, Carlsbad, CA, United States
Products
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2526-2026Want us to check the next one for you?
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