Z-2526-2026Class II

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

Name: Z-2526-2026 Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Creator: Pfm Medical Inc.
Published: 2026-04-21
License: https://open.fda.gov/license/

PFM Medical GmbH / initiated 2026-04-21 / Open, Classified

FDA source

PFM MEDICAL INC. began a recall of Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 on 2026-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2526-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-21
Posted: 2026-06-23
Recalling firm: PFM Medical GmbH
Product: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Product code: DXE Catheter, Embolectomy
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.
FDA root cause: Under Investigation by firm
Action: On 4/21/2026, recall notices were emailed to customers who were asked to do the following: 1. Inform all customers (hospitals and clinics) and device users (physicians) who have received or used affected batches. This notification should also be shared with any organizations where the potentially affected devices have been transferred. 2. Return unused devices from the affected batches to PFM Medical, Inc. 3. Complete the enclosed Recall Response Form and email back to [email protected]
Quantity in commerce: 32
Distribution: US Nationwide distribution in the states of NY, MD.
Product codes and lots: REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2526-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2526-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23

Product code DXE

K011783Class IIMulti-Snare SetPfm Produkte Fur Die Medizin AG / cleared 2002-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)