Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Medtronic Reveal LINQ LNQ11 / PA96000

FDA Recall Z-2102-2021 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusOpen, Classified
Product CodeMXD
Date Initiated2021-06-01
Product Quantity666210 devices

Reason for Recall

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.

Firm Action

The firm began notifying their consignees on 06/02/2021 by letter. The letter explained the issue, provided patient management recommendations, and reported that a software update was anticipated in late 2021. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-929-4043.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162855Reveal LINQMedtronic, Inc. · 2017-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑