Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Summary
The FDA issued a Class II for Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 by PFM MEDICAL INC.. Reason: A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibil.
Details
Source
Device Recall
External ID
Z-2526-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Lot/Code Info: REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Quantity Affected: 32
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.
Distribution
US Nationwide distribution in the states of NY, MD.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-21
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.
PFM MEDICAL INC. has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PFM MEDICAL INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PFM MEDICAL INC. have FDA actions?
PFM MEDICAL INC. has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2526-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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