VISIONIST CRT-P, X4 CRT-P and Autogen CRT-D (2017-12-19)
In plain language
This recall involves VISIONIST CRT-P, X4 CRT-P, and Autogen CRT-D medical devices. They are being recalled because a programming issue could lead to the device entering a safety mode, requiring early replacement. Patients with these devices should consult their healthcare provider for important programming information.
What to do
- Consult your healthcare provider for important programming information.
- Do not attempt to remove or modify the device yourself.
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Affected products
AUTOGEN CRT-D
Model: G172, G173, G175, G179
Lot: Not applicable
VISIONIST CRT-P
Model: U225
Lot: Not applicable
VISIONIST X4 CRT-P
Model: U228
Lot: Not applicable
Why this matters
Device malfunction requiring early replacement
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: Not applicable
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: G172, G173, G175, G179, U225, U228
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?
Device malfunction requiring early replacement
What should consumers do?
Consult your healthcare provider for important programming information. Do not attempt to remove or modify the device yourself.
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. Device malfunction requiring early replacement
When was this product recalled?
This product was recalled on January 29, 2018.