Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
Animas Corporation is recalling 1,235 Vibe Insulin Infusion Pumps because calibration factors were overwritten, potentially causing the pump to fail to detect cartridges or alarms.
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, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from insulin delivery failure in a medical device.
Plain-English summary
Animas Corporation is recalling 1,235 units of the Animas Vibe Insulin Infusion Pump. This medical device is indicated for the continuous subcutaneous infusion of insulin for the treatment of diabetes and includes a continuous glucose monitoring feature. The recall is due to a defect where calibration factors in the pump were overwritten during a programming step.
The defect causes the force sensor to send a lower signal value to the pump processor. As a result, the pump may experience loss of prime warnings, occlusion alarms, and an inability to detect a cartridge during the prime sequence. The field action for this recall was initiated on August 29, 2011.
The affected units were not distributed in the United States. Distributors for these products are located in France, Germany, Sweden, and the United Kingdom. Consumers and healthcare providers in these regions should contact Animas Corporation for further instructions regarding the field action.
The recalled product
- Product
- Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
- Manufacturer
- Animas Corporation
- Category
- Medical Device — Insulin Pump
- Affected units
- 1,235
Distribution
Distribution scope not specified by the agency.
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