Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-2102-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Medtronic Reveal LINQ LNQ11 / PA96000

Product Classification:

Class II

Date Initiated: June 1, 2021

Date Posted: July 28, 2021

Recall Number: Z-2102-2021

Event ID: 88175

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.

Status: Ongoing

Product Quantity: 666210 devices

Code Information:

All serial numbers distributed on or after February 23, 2017 GTIN: 643169845763, 643169845770, 643169845787, 643169845794, 643169845800, 643169845817, 643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429, 00763000188436, 00763000188443, 00763000188450, 00763000188467, 643169845688, 643169845695, 643169845701, 643169845718, 643169845732, 643169845749, 643169845756

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated