Intragastric balloons recall in Canada: risk of perforation and pancreatitis
In plain language
This recall involves several brands of intragastric balloons used for weight loss in Canada. They are being recalled due to a potential risk of gastric and esophageal perforation, pancreatitis, and balloon overinflation. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Orbera System Intragastric Balloon
Model: 72168
Spatz3 Adjustable Balloon System Insertion Kit
Model: 93172
Endball – Systeme de Ballon Intra-gastrique
Model: 90070
Reshape Medical Intragastric Balloon
Model: 84060
Why this matters
Risk of gastric and esophageal perforation, pancreatitis, and overinflation
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 72168, 84060, 90070, 93172
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Risk of gastric and esophageal perforation, pancreatitis, and overinflation
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return, repair, or dispose of it as instructed.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Risk of gastric and esophageal perforation, pancreatitis, and overinflation
When was this product recalled?
This product was recalled on April 17, 2019.