Intragastric Balloons And Potential Risk Of Gastric And Esophageal Perforation, Pancreatitis, And Overinflation

Recall Summary Intragastric balloons used for weight management are being recalled in Canada because they may rupture or overinflate, potentially causing serious complications including holes in the stomach or esophagus, and pancreatitis. The devices were distributed across Canada. This recall affects patients who have had or are considering this type of balloon implant.

Reason

Product safety

Category

drug recall

Country

Canada

Agency

HC-DRUGS

Recall date

2019-04-17

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DRUGS

Recall details on Nibble Recalls: https://trynibble.app/recalls/79ae37bf-cb3a-408f-bb00-a5f143779463