Medtronic Reveal LINQ LNQ11 / PA96000
Reported: July 28, 2021 Initiated: June 1, 2021 #Z-2102-2021
Product Description
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.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 666210 devices
- Distribution
- Worldwide Distribution
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Reveal LINQ LNQ11 / PA96000. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 666210 devices.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2102-2021.
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