—#188051

Product

Medtronic Reveal LINQ LNQ11 / PA96000

FDA product code: MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K162855
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2021-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188051. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.