Recall Z-0640-2018— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2017-09-21, terminated 2018-09-26. It names 2 FDA 510(k) clearances: K160654, K143083. Product: 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.. Reason: Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-21
- Terminated
- 2018-09-26
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
2 on FDA's record- K160654 — GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
- K143083 — Bio-Medicus Pediatric Cannula and Introducers
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.