Medical Device Recall: Z-0034-2026

FDA Recalls dataset · Firm: LeMaitre Vascular, Inc. · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2025-09-02 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2026.

Recall Res Number
Z-0034-2026
Recalling Firm / Manufacturer
LeMaitre Vascular, Inc.
FEI Number
1000121696
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2025-09-02
Date Posted
2025-10-02
Date Terminated
N/A
Product Code
LXA
Event Number
97518
Product Quantity
28 units
Product Description Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Reason for Recall The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Action Details On September 2, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. 2. Complete and return attached response form. 3. If the product has been implanted, graft explantation/patient intervention is NOT required. 4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 5. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Monte Nelson; mnelson@lemaitre.com; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Distribution Pattern US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
Code Information / Serial Numbers Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030; UDI-DIs: (1) 00316837000213, (2) 00316837000220, (3) 00316837000237, (4) 00316837000244, (5) 00316837000251, (6) 00316837000268, (7) 00316837000275, (8) 00316837000282, (9) 00316837000299, (10) 00316837000305, (11) 00316837000312, (12) 00316837000367, (13) 00316837000329, (14) 00316837000343, (15) 00316837000350; Serial Numbers: (1) 23DD203-019, 23DD203-046, (2) 23DD203-024, 23DD203-029, (3) 23DD203-045, (4) 23DD203-018, (5) 23DD203-004, (6) 23DD203-021, 23DD203-044, 23DD203-038, 23DD203-039, 23DD203-011, 23DD203-032, 23DD203-031, 23DD203-043, (7) 23DD203-040, 23DD203-030, 23DD203-037, (8) 23DD203-035, 23DD203-033, (9) 23DD203-034, (10) 23DD203-036, (11) 23DD203-022, 23DD203-023, (12) 23DD203-017, (13) 23DD203-027, (14) 23KK498-014, (15) 23DD203-026;

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.