Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic Reveal LINQ LNQ11 / PA96000 Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Reveal LINQ with TruRhythm ICMs, that undergo a...

Date: June 1, 2021
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.

Affected Products

Medtronic Reveal LINQ LNQ11 / PA96000

Quantity: 666210 devices

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide Distribution

About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report