FDA Medical Device Recalls (openFDA)
PFM MEDICAL INC.: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
- Recall number
- Z-2526-2026
- Recalling firm
- PFM MEDICAL INC.
- Product
- Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
- Status
- Open, Classified
- Initiated
- 2026-04-21
- Posted
- 2026-06-23
- Terminated
- not on file
- 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.
- 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 recall@pfmmedicalusa.com
- Quantity
- 32
- Distribution
- US Nationwide distribution in the states of NY, MD.
- Lot, serial or model codes
- REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
- 510(k) numbers
- ["K011783"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 3013666218
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28