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

Recall Z-0843-2021 — CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000

U.S. FDA — Device Enforcement · United States · 2020-11-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0843-2021
Date of alert
2020-11-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000424121
Reported risk: Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
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.