iLet Bionic Pancreas pumps may become stuck on the lock screen
The iLet Bionic Pancreas is being recalled because a screen unlock failure can leave the user stuck on the Lock Screen, unable to change the cartridge or announce a meal.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with a stated risk of hyperglycemia when the user cannot change the cartridge or announce a meal, a risk of harm with no injuries reported.
Plain-English summary
The iLet Bionic Pancreas, REF BB1001, from Beta Bionics, Inc., is being recalled. The action covers 4,580 units running iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and Rev B (version 3.3.4).
It was found in version 3.3.6 of the firmware and all previous releases that a screen unlock failure could occur: the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, they are unable to perform a cartridge change or meal announcement. According to the manufacturer, if this occurs while therapy is in progress, therapy will continue normally until the insulin cartridge is depleted, and the user will be stuck on the screen until the battery fully drains, which can lead to hyperglycemia. The FDA classified the action as Class II.
Distribution was nationwide in the United States across a large number of states.
Users and prescribers should identify affected pumps using the REF and firmware versions above and follow the instructions issued by Beta Bionics.
The recalled product
- Product
- iLet Bionic Pancreas, REF: BB1001
- Manufacturer
- Beta Bionics, Inc.
- Affected units
- 4,580
Distribution
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