AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Graf...
FDA Device Recall #Z-1770-2013 — Class I — June 17, 2013
Recall Summary
| Recall Number | Z-1770-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | June 17, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LeMaitre Vascular, Inc. |
| Location | Burlington, MA |
| Product Type | Devices |
| Quantity | 3 units |
Product Description
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Reason for Recall
Blood blushing/leaking from the surface of the graft after implantation
Distribution Pattern
Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
Lot / Code Information
Lot number/Expiration Date 56890A 2015-04
Other Recalls from LeMaitre Vascular, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1574-2026 | Class II | Artegraft Vascular Graft; REF#: AG740; | Feb 10, 2026 |
| Z-0289-2026 | Class II | Artegraft¿ Collagen Vascular Graft; REF: AG1015; | Sep 25, 2025 |
| Z-0034-2026 | Class II | Artegraft Collagen Vascular Grafts Model Numbe... | Sep 2, 2025 |
| Z-0072-2026 | Class II | Artegraft Collagen Vascular Graft. Model/Catal... | Aug 25, 2025 |
| Z-1751-2025 | Class II | Pruitt Occlusion Catheter. Catalog Numbers: 210... | Apr 11, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.