FDA recall Z-2102-2021

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

Medtronic Reveal LINQ LNQ11 / PA96000

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.

Distribution

Worldwide Distribution

Key facts

Status: Ongoing
Initiation date: 2021-06-01
Report date: 2021-07-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2021