Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: ...
FDA Device Recall #Z-0819-2016 — Class II — December 2, 2015
Recall Summary
| Recall Number | Z-0819-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 2, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 364,768 units |
Product Description
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Reason for Recall
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
Lot / Code Information
RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0289X P5C0196X through P5C0197X P5C0304X through P5C0307X P5C0796X through P5C0798X P5D0049X through P5D0051X P5D0146X through P5D0148X P5E0261X through P5E0262X P5F0158X through P5F0161X INDIVIDUAL LOT NUMBERS (in addition to ranges) N3F0260RX N3F0266RX N3F0267RX P5C0201X P5D0538X P5E0680X P5E0682X P5E0686X P5E0760X P5E0762X P5E0765X
Other Recalls from Medtronic
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2548-2017 | Class II | SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 | May 3, 2017 |
| Z-2543-2017 | Class II | Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 4... | May 3, 2017 |
| Z-2547-2017 | Class II | CUSTOM SUTURE PACK; Item Number: US1540 and US1614 | May 3, 2017 |
| Z-2545-2017 | Class II | Best Practice Kit, Item Numbers: 00Z2064, 00Z21... | May 3, 2017 |
| Z-2544-2017 | Class II | Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 D... | May 3, 2017 |
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.