Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MultiSnare

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MultiSnaresee related information
Date Initiated by FirmApril 21, 2026
Date PostedJune 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2526-2026
Recall Event ID 98942
510(K)NumberK011783 
Product Classification Catheter, embolectomy - Product Code DXE
ProductMulti-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Code Information REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
FEI Number 3013666218
Recalling Firm/
Manufacturer		 PFM MEDICAL INC.
1916 Palomar Oaks Way
Carlsbad CA 92008-5523
For Additional Information Contact
760-758-8749 Ext. 222
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce32
DistributionUS Nationwide distribution in the states of NY, MD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXE
-
-