Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The ...
FDA Device Recall #Z-0820-2016 — Class II — December 2, 2015
Recall Summary
| Recall Number | Z-0820-2016 |
| 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 | 1,102,166 units |
Product Description
Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND 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 P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X P5E0080X through P5E0082X P5E0317X through P5E0320X P5E0322X through P5E0324X P5F0001X through P5F0002X INDIVIDUAL LOT NUMBERS (in addition to ranges) P5C0239X, P5C0241X, P5C0508X, P5C0510X, P5C0512X, P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X P5D0067X, P5D0069X , P5D0073X, P5D0170X, P5D0413X, P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X P5D0630X, P5E0525X, P5F0004X, P5F0006X, P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X
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.