PFM Medical Multi-Snare Sets
The Multi-Snare Set failed to meet biocompatibility requirements, which could cause localized inflammation and tissue irritation.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
PFM Medical Inc. of Carlsbad, California, began a recall on April 21, 2026, for the Multi-Snare Set: 5 mm x 125 cm, REF: 147305, and the 10 mm x 125 cm, REF: 147310.
The snare catheter, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which could result in localized inflammation and tissue irritation if in contact with a patient's vasculature.
The FDA added the recall to its Enforcement Report and classified it on June 23, 2026, with distribution in New York and Maryland.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Affected if its UDI-DI and lot code are listed under that product.
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
- UDI-DI
- 04042301061829
- 04042301033567
- Lot
- 147305
- 1049868
Details
- Company began the recall
- Event ID
- 98942
- Recall No.
- Z-2526-2026
- Company
- PFM MEDICAL INC.Carlsbad, California
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
