Insulin pumps recalled for software malfunctions affecting blood glucose control
Tandem Diabetes Care is recalling 31,100 t:slim X2 insulin pumps due to software issues that could cause inaccurate insulin delivery, potentially leading to dangerous blood sugar levels. A software update is available to address the issues.
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: FDA Class II medical device recall affecting insulin pump software. While no injuries have been reported, the potential consequences (hypoglycemia, hyperglycemia, diabetic ketoacidosis) are serious. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tandem Diabetes Care Inc. is recalling the t:slim X2 insulin pump, including variants with Dexcom G5, Basal-IQ technology, and Control-IQ technology. Approximately 31,100 units are affected.
The recalled pumps may experience four issues: malfunction of non-volatile memory, inaccurate or fluctuating battery life display, touchscreen staying on unexpectedly, and unexpected open loop mode. These issues can be mitigated with a software update and could result in hypoglycemia, hyperglycemia, or diabetic ketoacidosis if left unaddressed.
The affected pumps were distributed throughout the United States, Puerto Rico, U.S. Virgin Islands, Australia, New Zealand, and South Africa.
Consumers should contact Tandem Diabetes Care Inc. to obtain the software update that addresses these issues.
The recalled product
- Product
- t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
- Manufacturer
- Tandem Diabetes Care Inc
- Category
- Medical Device — Insulin Pump
- Hazard
- non-volatile-memory-malfunction
- battery-display-error
- touchscreen-malfunction
- unexpected-open-loop
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 (20)
- 00852162004798
- 00853052007240/ 4.3.5.2
- 4.3.6/ For Distributors
- All Parts
- Contact Recalling Firm to Switch Out
- t:slim X2 insulin pump with Dexcom G5/853052007257
- 853052007271
- 853052007295
- 853052007318
- 853052007967
- 853052007981/ 5.0.1
- 5.0.4
- 5.3.1.1/ For Distributors
- t:slim X2 insulin pump with Basal-IQ technology/853052007264
- 853052007288
- 853052007301
- 853052007325
- 850006613373
- 850006613380
- 850006613700
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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