Medtronic Reveal LINQ implantable monitor may fail to detect heart rhythm events
Medtronic Reveal LINQ cardiac monitors may stop detecting dangerous heart rhythm abnormalities after partial electrical reset, potentially delaying clinical response.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with significant loss of critical detection function (inability to detect bradycardia and pause events). No reported illnesses or injuries have been documented, placing this in the 'risk-of-harm' category where serious patient harm could result if the defect is not addressed.
Plain-English summary
Medtronic Reveal LINQ LNQ11 / PA96000 implantable cardiac monitors are being recalled due to a defect that occurs after partial electrical reset. When affected, the devices appear to remain programmed as active but are no longer able to detect and report bradycardia and pause events to clinicians.
This defect prevents the device from performing its critical function of monitoring and alerting healthcare providers to dangerous heart rhythm abnormalities. Approximately 666,210 affected devices were distributed worldwide to patients who rely on these monitors for cardiac rhythm surveillance.
Patients with an implanted Reveal LINQ monitor should contact their healthcare provider to determine if their device is affected and to discuss appropriate monitoring and management options.
The recalled product
- Product
- Medtronic Reveal LINQ LNQ11 / PA96000
- Affected units
- 666,210
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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