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

Recall Z-1609-2024 — t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

U.S. FDA — Device Enforcement · United States · 2024-03-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1609-2024
Date of alert
2024-03-05
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Tandem Diabetes Care, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850006613274
Reported risk: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
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.

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.