Reported Jul 28, 2021 · Ongoing
Medtronic Reveal LINQ LNQ11 / PA96000
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Medtronic Reveal LINQ LNQ11 / PA96000
- Lot codes and dates
- All serial numbers distributed on or after February 23, 2017
- GTIN
643169845763643169845770643169845787643169845794643169845800643169845817643169845824006431698458310064316984584800643169845855006431698458620064316984587900643169845893007630001883820076300018839900763000188405007630001884120076300018842900763000188436007630001884430076300018845000763000188467643169845688643169845695643169845701643169845718643169845732643169845749643169845756
- Amount recalled
- 666210 devices
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.
This product could cause temporary or reversible health problems — stop using it.
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