Micra MC1VR01 recall in Canada: May prevent pacemaker release
In plain language
This recall involves the Micra MC1VR01 medical device in Canada. It's being recalled because a specific flushing procedure could prevent the pacemaker from being released. Healthcare professionals should follow updated instructions for use.
What to do
- Stop using the previous flushing procedure.
- Follow the updated instructions for use (IFU) and implant procedure tip card.
- Ensure the tether is fully removed before flushing the delivery system.
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Affected products
Micra MC1VR01
Model: MC1VR01
Lot: All lots
Why this matters
May prevent pacemaker release
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: MC1VR01
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
May prevent pacemaker release
What should consumers do?
Stop using the previous flushing procedure. Follow the updated instructions for use (IFU) and implant procedure tip card. Ensure the tether is fully removed before flushing the delivery system.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. May prevent pacemaker release
When was this product recalled?
This product was recalled on August 23, 2019.
Is the Micra brand affected by this recall?
Yes, Micra products are affected by this recall. This recall involves the Micra MC1VR01 medical device in Canada. It's being recalled because a specific flushing procedure could prevent the pacemaker from being released. Healthcare professionals should follow updated instructions for use.