Animas Vibe Insulin Infusion Pump Recalled for Keypad Wear Issues
Animas Corporation is recalling 1,938 Vibe Insulin Infusion Pumps because keypad wear over time contributes to damage. The recall covers units distributed in France, Italy, Sweden, and the UK.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (keypad wear) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Animas Corporation is recalling 1,938 units of the Animas Vibe Insulin Infusion Pump and System. The recall is due to keypad wear over time, which has contributed to an increased complaint rate associated with damaged keypads. The affected products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
The recall covers units distributed worldwide in France, Italy, Sweden, and the UK. The specific part numbers affected are listed in the structured product information. Animas has implemented an improvement to the keypad material to reduce susceptibility to damage and increase durability.
Consumers with affected devices should contact Animas Corporation for further instructions on how to proceed with the recall and any necessary repairs or replacements.
The recalled product
- Product
- Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
- Manufacturer
- Animas Corporation
- Category
- Medical Device — Insulin Pump
- Hazard
- Affected units
- 1,938
Distribution
Distribution scope not specified by the agency.
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Similar recalls
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FDA (Devices) · 2012-10-10
- SevereAnimas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
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