Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2526-2026·Announced 2026-07-01

Multi-Snare Set catheter fails biocompatibility requirements

PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is biocompatibility failure with theoretical risk of inflammation and tissue irritation if contact occurs, but no actual harm has been documented in the source text.

Plain-English summary

PFM Medical Inc. is recalling Multi-Snare Set snare catheters in two sizes: 5 mm x 125 cm (REF 147305) and 10 mm x 125 cm (REF 147310). These devices are used to remove or manipulate foreign bodies in the vascular system.

The snare catheters failed to meet biocompatibility requirements for in-vitro cytotoxicity. If the devices come into contact with a patient's vasculature, they could result in localized inflammation and tissue irritation.

The recalled devices were distributed nationwide in New York and Maryland. Affected lot numbers and expiration dates are: REF 147305, Lot 1049868 (expires 10/14/2028); and REF 147310, Lot 1049960 (expires 10/20/2028). A total of 32 units were affected.

Patients and healthcare providers who have used or received these devices should contact PFM Medical Inc. for further guidance.

The recalled product

Product: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Manufacturer: PFM MEDICAL INC.
Category: Medical Device — Catheter / Vascular Device
Hazard: biocompatibility-failure
cytotoxicity
tissue-irritation
Affected units: 32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028)
147310/04042301033567/1049960(10/20/28)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · PFM MEDICAL INC.

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