CLASS II ONGOING Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
Medtronic Reveal LINQ LNQ11 / PA96000 recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Medtronic Reveal LINQ LNQ11 / PA96000. The recall was initiated on 1 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2102-2021
- FDA event ID
- 88175
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2021
- FDA classified
- 20 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2021 | Recall initiated by company | |
| 20 Jul 2021 | Classified by FDA | +49 days |
| 28 Jul 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Medtronic Reveal LINQ LNQ11 / PA96000
Where it was distributed
Worldwide Distribution
Questions about this recall
Is Medtronic Reveal LINQ LNQ11 / PA96000 recalled?
Yes. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Medtronic Reveal LINQ LNQ11 / PA96000 on 1 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-2102-2021.
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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