[pending] Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion p
Pending LLM rewrite. Source: FDA_DEVICE Z-0427-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
The recalled product
- Product
- Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,
- Manufacturer
- Tandem Diabetes Care, Inc.
- Category
- Medical Device — Devices
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 (9)
- Software versions: 7.6.0.1
- 7.6.0.3
- and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013
- 1012719/00389152271910
- 1013501/00389152350110
- 1013655/00389152365510
- 1013656/00389152365619
- 1013700/00389152370019
- 1014081/00389152408170
Distribution
Distributed in 53 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VI
- VT
- WA
- WI
- WV
- WY
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