Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for ...
FDA Device Recall #Z-0748-2021 - Class II, November 23, 2020
Recall Summary
| Recall Number | Z-0748-2021 |
| Classification | Class II - Moderate risk |
| Date Initiated | November 23, 2020 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien Llc |
| Location | Mansfield, MA |
| Product Type | Devices |
| Quantity | 5316 units US; 1209 units OUS |
Product Description
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
Reason for Recall
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
Distribution Pattern
Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martinique Morocco Myanmar, Netherlands Norway Pakistan Poland Russian Federation Serbia Singapore Slovakia Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Viet Nam
Lot / Code Information
Lot Numbers: P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY,P0D1444MY, P0E1211MY, P0F0606MY. UDI: 10884521043152, 20884521043159
Other Recalls from Covidien Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2272-2026 | Class II | Covidien Mon-a-Therm General Purpose Temperatur... | Apr 23, 2026 |
| Z-2273-2026 | Class II | Covidien Mon-a-Therm general purpose temperatur... | Apr 23, 2026 |
| Z-2271-2026 | Class II | Covidien Mon-a-Therm Esophageal Stethoscope wit... | Apr 23, 2026 |
| Z-2653-2026 | Class II | Covidien Shiley Disposable Decannulation Plug ... | Apr 23, 2026 |
| Z-2261-2026 | Class II | COVIDIEN Shiley Tracheostomy Tube Cuffed with I... | Apr 15, 2026 |
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.