Vectris SureScan MRI Leads recall in Canada: potential manufacturing defect
In plain language
This recall involves Vectris SureScan MRI Leads and Vectris Trialing Leads sold in Canada. They are being recalled because a manufacturing defect in the introducer needle could make it difficult to advance or withdraw the lead. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Medtronic Inc. for more information.
- Follow the instructions from your healthcare professional.
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Affected products
Vectris SureScan MRI Leads
Model: 977A160, 977A175, 977A190, 977A260, 977A275, 977A290
Lot: More than 10 numbers, contact manufacturer.
Date codes: use by date beginning 2021-10-31 through 2022-03-08
Vectris Trialing Leads
Model: 977D160, 977D260
Lot: More than 10 numbers, contact manufacturer.
Date codes: use by date beginning 2021-10-31 through 2022-03-08
Why this matters
Difficulty advancing or withdrawing the lead during medical procedures
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 date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: use by date beginning 2021-10-31 through 2022-03-08
- 3
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 4
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 977A160, 977A175, 977A190, 977A260, 977A275, 977A290, 977D160, 977D260
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?
Difficulty advancing or withdrawing the lead during medical procedures
What should consumers do?
Stop using the product immediately. Contact Medtronic Inc. for more information. Follow the instructions from your healthcare professional.
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. Difficulty advancing or withdrawing the lead during medical procedures
When was this product recalled?
This product was recalled on June 14, 2018.
Is the Vectris brand affected by this recall?
Yes, Vectris products are affected by this recall. This recall involves Vectris SureScan MRI Leads and Vectris Trialing Leads sold in Canada. They are being recalled because a manufacturing defect in the introducer needle could make it difficult to advance or withdraw the lead. Stop using the product and follow the return steps in the official notice.