Official recall notice
FDA Recall: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
- Recall date
- 2026-07-01
- Brand
- PFM MEDICAL INC.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)