Medtronic LINQ II Insertable Cardiac Monitor Detection Failure Recall
Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.
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: This is an FDA Class II recall involving a risk-of-harm scenario where an implanted cardiac monitoring device may fail to detect critical arrhythmias. No illnesses or injuries are reported in the source text, but the potential for serious harm is significant given the device's safety-critical monitoring function.
Plain-English summary
Medtronic Inc. is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only. This is a small implantable device designed to continuously monitor heart rhythm and detect abnormal cardiac events.
The device may fail to detect important cardiac arrhythmias—specifically bradycardia episodes (abnormally slow heartbeats), asystole episodes (absence of heart contractions), and premature ventricular contractions (irregular heartbeats)—after the device undergoes a power-on reset.
Approximately 21,685 affected devices have been distributed worldwide, including across all U.S. states and territories, as well as to Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom.
Patients with this device should contact their healthcare provider or Medtronic immediately to discuss the recall and any potential risks. Do not attempt to address this issue independently. Patients should continue to follow their physician's guidance regarding their cardiac care and monitoring.
The recalled product
- Product
- Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
- Affected units
- 21,685
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 (1)
- Model Number: LNQ22
Distribution
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