Recall Z-0640-2018 ยท KNT Tubes, Gastrointestinal (And Accessories)
Covidien LLC
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guid
| Date | Sep 21, 2017 |
| Status | Terminated |
| Reason | Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used. |
| Root cause | Under Investigation by firm |
| Action | Medtronic sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2017 to their customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review inventory and notify firm if any product remains at their facility. Arrangements for product return would then be made. For questions or concerns can be directed to customerservice@Covidien.com |
| Quantity | 17,271 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |