Multi-Snare Set: 5 mm x 125 cm, REF: 147305 recallZ-2526-2026 · Pfm Medical Inc. · initiated Apr 21, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pfm Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-2526-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 21, 2026
- Posted by the FDA
- Jun 23, 2026
- Recalling firm
- Pfm Medical Inc.
- Quantity
- 32
- Product code
- DXE
- FDA submissions
- K011783
- Distribution
- US Nationwide distribution in the states of NY, MD.
Product description
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Code information (models, lots, serial numbers)
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Multi-Snare 147310pfm medical mepro gmbh · Catheter, Embolectomy1 recall0 reports
- Multi-Snare 147305pfm medical mepro gmbh · Catheter, Embolectomy1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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