Medtronic Micra Pacemaker Documentation Update for Tether Removal
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves an update to documentation (Instructions for Use and Tip Card) to include specific procedural information, which aligns with the rubric criteria for documentation issues and packaging-only problems.
Plain-English summary
Medtronic Inc. is updating the Instructions for Use (IFU) and the Implant Procedure Tip Card for the Micra MC1VR01 single chamber transcatheter pacing system. The update includes specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during the implant procedure.
This action affects the Micra MC1VR01 single chamber transcatheter pacing system, reference MC1VR01US, which is distributed worldwide. The recall involves 24,521 units of the device.
The update is intended to ensure that specific procedural information regarding tether removal is available to medical professionals during the implant process.
The recalled product
- Product
- Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
- Hazard
- Affected units
- 24,521
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 (2)
- REF MC1VR01US
- GTIN 00643169529748
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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