FDAJune 1, 2021device

Medtronic Reveal LINQ LNQ11 / PA96000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

6431698457636431698457706431698457876431698457946431698458006431698458176431698458240064316984583100643169845848006431698458550064316984586200643169845879

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Medtronic Reveal LINQ LNQ11 / PA96000 — Recall Details · AllClear