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U.S. Department of Health and Human Services

Class 2 Device Recall iLet ACE Pump

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 Class 2 Device Recall iLet ACE Pumpsee related information
Date Initiated by FirmMarch 12, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1996-2026
Recall Event ID 98475
510(K)NumberK252770 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductiLet Bionic Pancreas, REF: BB1001
Code Information Software versions 1.4.3, and 1.4.2
FEI Number 3019004087
Recalling Firm/
Manufacturer		 Beta Bionics, Inc.
11 Hughes
Irvine CA 92618-1902
For Additional Information ContactKaren Hynes
855-745-3800
Manufacturer Reason
for Recall		insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
FDA Determined
Cause 2		Software change control
ActionOn 3/12/2026, correction notices were emailed to customers who were asked to do the following: Update device software to host software 1.4.4 and up. Update your software 1. Download or update your iLet app on your phone. Read the iLet App User Guide: https://www.betabionics.com/wp-content/uploads/LA000056_F-iLet-Mobile-App-User-Guide.pdf 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. -Distributors are asked to provide patient contact information so the firm can provide the correction notice to these patients. - Complete the acknowledgment survey https://sprw.io/stt-6HnQU If you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.
Quantity in Commerce1,080
DistributionUS Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QFG
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