Recall Z-2526-2026— PFM MEDICAL INC.

Name: FDA recall Z-2526-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Class II · Ongoing

Class II FDA medical device recall by PFM MEDICAL INC., initiated 2026-04-21. It names one FDA 510(k) clearance: K011783. 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..

Recalling firm: PFM MEDICAL INC.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-21
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K011783 — MULTI-SNARE SETPfm Produkte Fur Die Medizin AG·cleared 2002-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.