Insulin pump app recalled over defect in right-to-left language settings
The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential incorrect therapy decisions leading to hypoglycemia or hyperglycemia, with no injuries reported.
Plain-English summary
The t:slim X2 Insulin Pump with Interoperable Technology, used with the Tandem t:slim mobile app, Android software version 2.9.1, UDI-DI 00389152470641, is being recalled. The recall covers 19 units distributed internationally in Israel.
The recall was issued because of an app defect that occurs when the phone is set to a right-to-left language, causing app-pump pairing issues and graphical defects. The manufacturer states this can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. The FDA classified the action as Class II.
Users should follow the manufacturer's instructions for updating the app and should contact their clinician about any therapy decision they are unsure of.
The recalled product
- Product
- t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
- Manufacturer
- Tandem Diabetes Care, Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Tandem t:slim Mobile App
Distribution
Distribution scope not specified by the agency.
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