Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
FDA device recall Z-2526-2026 · posted 2026-06-23 · Open, Classified
Recall details
- Recalling firm
- PFM MEDICAL INC.
- 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.
- Action taken
- On 4/21/2026, recall notices were emailed to customers who were asked to do the following: 1. Inform all customers (hospitals and clinics) and device users (physicians) who have received or used affected batches. This notification should also be shared with any organizations where the potentially affected devices have been transferred. 2. Return unused devices from the affected batches to PFM Medical, Inc. 3. Complete the enclosed Recall Response Form and email back to recall@pfmmedicalusa.com
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DXE
- Quantity affected
- 32
- Distribution
- US Nationwide distribution in the states of NY, MD.
- Date initiated
- 2026-04-21
- Date posted
- 2026-06-23
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTI-SNARE SET (K011783) | Pfm Produkte Fur Die Medizin AG | 2002-01-24 |