Recall Z-2343-2025 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
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: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF
| Date | Aug 27, 2025 (initiated Jul 21, 2025) |
| Status | Open, Classified |
| Reason | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization. |
| Root cause | Nonconforming Material/Component |
| Action | On 7/21/2025, correction notices were mailed or emailed to customers were informed of the following: Confirm whether your pump is affected with serial number lookup: www.tandemdiabetes.com/mal16-2025 1) If you haven't had a Malfunction 16, continue using your Tandem pump as described in the User Guide, but with added precautions because the Malfunction 16 can occur at any time. 2) Use the Tandem t:slim mobile app with push notifications turned on so if the malfunction does occur, you will be notified by the app. If you need assistance with enabling smartphone notifications to receive alerts |
| Quantity | 171,750 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech Republic, Slovakia, Spain, United Kingdom, Belgium, Luxembourg, Australia, France, Italy, New Zealand, Finland, Sweden, Denmark, Norway, Saudi Arabia, Germany, Netherlands, Ireland, Portugal, South Africa, Switzerland |
| FDA record | Open on fda.gov |