Pfm Medical Inc.: Catheter, Embolectomy
Recall Summary PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm x 125 cm and 10 mm x 125 cm) used to remove foreign objects from blood vessels because they failed safety testing for tissue compatibility. If used, these devices could cause localized inflammation and tissue irritation in the blood vessels. The catheters were distributed nationwide.
- Recalling firm
- PFM MEDICAL INC.
- Product
- Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of NY, MD.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/efc97684-6784-4221-ab81-14e7d81f8828