FDA DevicesClass II
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Published: July 1, 2026Recall ID: Z-2526-2026Category: devicesCountry: US
Reason for Recall / 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 & Identification
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Additional Source Details
| Field | Value |
|---|---|
| City | Carlsbad |
| State | CA |
| Event id | 98942 |
| Address 1 | 1916 Palomar Oaks Way |
| Address 2 | N/A |
| Code info | REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28) |
| Postal code | 92008-5523 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 32 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260421 |
| Initial firm notification | N/A |
| Center classification date | 20260623 |
Overview
- Recalling FirmPFM MEDICAL INC.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of NY, MD.