Beta Bionics, Inc.: iLet Bionic Pancreas, REF: BB1001

Company / brand

Beta Bionics, Inc.

Product

iLet Bionic Pancreas, REF: BB1001

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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

Recall initiated

2025-09-23

Code info

iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)

Product quantity

4580

Voluntary mandated

Voluntary: Firm initiated

City

Irvine

State

CA

Country

United States

Event id

98517

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