Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1811-2022 — 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

U.S. FDA — Device Enforcement · United States · 2022-05-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1811-2022
Date of alert
2022-05-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Tandem Diabetes Care Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00852162004781
Reported risk: Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.