GastriSail Gastric Positioning Device Recalled Due to Perforation Reports
FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of significant injury (gastric or esophageal perforation), which meets the criteria for a Severe (4) rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 17,271 units of the GastriSail Gastric Positioning Device manufactured by Covidien LLC. The device is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression, and to radially expand the stomach. The recall is being conducted because of reports of gastric or esophageal perforation occurring in procedures where the device was used.
The affected product numbers are GPS36 (Pediatric) and GPS40 (Adult). The recall covers specific lot codes ranging from E6J0001X to E7E0003X. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions. Patients who have had procedures involving these devices should consult their healthcare provider if they experience symptoms related to gastric or esophageal injury.
The recalled product
- 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…
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 17,271
Distribution
Distributed nationwide across the United States.
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