BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL...
FDA Device Recall #Z-1866-2018 — Class II — April 26, 2018
Recall Summary
| Recall Number | Z-1866-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 26, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | COVIDIEN MEDTRONIC |
| Location | NORTH HAVEN, CT |
| Product Type | Devices |
| Quantity | 169,775 units in total |
Product Description
BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
Reason for Recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Distribution Pattern
Worldwide and US Nationwide
Lot / Code Information
Lots:0215122344
Other Recalls from COVIDIEN MEDTRONIC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2511-2018 | Class II | Endo GIA 45 mm Articulating Vascular/Medium Loa... | May 22, 2018 |
| Z-2516-2018 | Class II | Tri-Staple 2.0 Curved Tip Intelligent Reload fo... | May 22, 2018 |
| Z-2503-2018 | Class II | Endo GIA 45 mm Articulating Medium/Thick Reload... | May 22, 2018 |
| Z-2509-2018 | Class II | Endo GIA 45mm Gray Articulating Vascular Reload... | May 22, 2018 |
| Z-2507-2018 | Class II | Tri-Staple 2.0 Black Intelligent Reload for use... | May 22, 2018 |
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.