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Recall Observatory FDA recall evidence

Device product

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

Z-2526-2026

April 21, 2026

Class II

Product summary

Firm
PFM MEDICAL INC.
Event
Event 98942
Status
Ongoing
Classification
Class II
Quantity
32
Official record key
device-enforcement:Z-2526-2026

Official wording

Reason: 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.

Code information: REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)

Distribution pattern: US Nationwide distribution in the states of NY, MD.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign body