Insulin Pumps Recalled for Speaker Malfunction and Inoperability Risk
Tandem Diabetes insulin pumps may malfunction due to defective speakers, preventing audible alerts and stopping insulin delivery. This could cause dangerous blood sugar spikes requiring hospitalization.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity of 4. The malfunction prevents audible alerts and causes complete pump inoperability, stopping insulin delivery and risking hyperglycemic episodes that may require hospitalization. No deaths or actual injuries have been reported.
Plain-English summary
Tandem Diabetes Care has recalled approximately 171,750 insulin pumps from the t:slim X2 family with various configurations (including Basal-IQ, Control-IQ, G5, GS Classic, and clinical use models). The recalled devices were manufactured with speakers from Revision A and B.
These pumps are subject to a malfunction (designated "Malfunction 16") in which the speaker fails. When the speaker malfunctions, the pump loses the ability to deliver audible alerts and becomes inoperable, stopping the delivery of insulin.
The malfunction affects pumps worldwide, including users in the United States, Canada, and across Europe and other regions. A failure to deliver insulin can result in dangerous elevated blood sugar levels (hyperglycemia), which may lead to injury and require hospitalization.
Patients using any of the affected pump models should contact Tandem Diabetes Care immediately to determine if their device is affected and to arrange replacement. Do not attempt to repair or continue using a pump suspected of malfunction.
The recalled product
- Product
- Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
- Manufacturer
- Tandem Diabetes Care, Inc.
- Hazard
- insulin-delivery-failure
- hyperglycemia
- alert-failure
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)
- REF/UDI-DI: 1000911/t:slim X2 G5
- Replacement
- Refurbished/00853052007318
- 1003808/t:slim X2 GS Classic
- Refurbished/ 00853052007981
- 1004219/t: slim X2
- Basal-IQ
- mg/dl/ 00853052007998
- 1004484/Pump
- t:slim X2
- Clinical Use Only
- 1005611/Pump
- Control-IQ
- mmoUL/ 00850006613304/
- 1005613/Pump
- mmoUL
- Refurbished Replacement/ 00850006613311/
- 1005615/Pump
- mg/dl/ 00850006613328/
- 1005617/Pump
Distribution
Distributed nationwide across the United States.
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