FDA-Device2026-06-24Class IIPROCESSING DEFECT

Beta Bionics iLet Bionic Pancreas recalled for screen unlock firmware failure

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What this means

A firmware bug in the iLet Bionic Pancreas can cause the lock screen to fail to unlock when users slide the unlock slider. When this happens, users become stuck on the lock screen and cannot change insulin cartridges or enter meal information. The pump will continue delivering insulin until the cartridge empties and the battery drains, which may lead to high blood sugar.

If your iLet Bionic Pancreas lock screen fails to unlock, monitor your blood sugar closely and manually check your insulin supply.
Contact Beta Bionics customer support or your healthcare provider for guidance on a firmware update or device replacement.
Do not rely solely on the device if you experience a lock screen failure; have a backup insulin delivery plan ready.

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The agency's original wording

Hazard

The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when 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, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

Intended for

Adults

Illnesses reported

None reported

Sold states

US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL

Affected count

4580

Manufactured in

11 Hughes, Irvine, CA, United States

Products

iLet Bionic Pancreas, REF: BB1001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2513-2026

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