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 guide for gastric and bariatric procedures, such as sleeve gastrectomy.
FDA Recall Z-0640-2018 · Posted None
Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeKNT
Date Initiated2017-09-21
Date Terminated2018-09-26
Product Quantity17,271 units
Reason for Recall
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
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 [email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.