Recall Z-2526-2026 ยท DXE Catheter, Embolectomy
PFM MEDICAL INC.
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
| Date | Jun 23, 2026 (initiated Apr 21, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 32 |
| Distribution | US Nationwide distribution in the states of NY, MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011783 | MULTI-SNARE SET Pfm Produkte Fur Die Medizin AG, Jan 24, 2002 |