Medtronic Micra Pacemaker Documentation Update for Tether Removal
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to clarify 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 is for a documentation update (Instructions for Use) to clarify procedural steps, which aligns with the rubric for documentation issues and packaging-only problems.
Plain-English summary
Medtronic Inc. is recalling 22,244 units of the Micra MC1VR01 cardiac pacemaker, which were distributed worldwide. The recall is initiated to update the product documentation, specifically the Instructions for Use (IFU) and the Micra Implant Procedure Tip Card.
The purpose of this recall is to include specific information regarding the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during the implant procedure. This update ensures that healthcare providers have the correct procedural guidance for device implantation.
Affected units are identified by specific serial numbers listed in the recall notice. Healthcare providers and patients should refer to the updated documentation provided by Medtronic for the correct procedure for tether removal during implant.
The recalled product
- Product
- Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
- Hazard
- Affected units
- 22,244
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)
- GTIN 00643169529731
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.
See all 2 products in this recall →Related recalls
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