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

Recall Z-2102-2021 — Medtronic Reveal LINQ LNQ11 / PA96000

U.S. FDA — Device Enforcement · United States · 2021-06-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2102-2021
Date of alert
2021-06-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
643169845763
Reported risk: Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
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.