Medtronic's EnTrust Dual Chamber recall in Canada: loss of therapy
In plain language
This recall involves Medtronic's EnTrust Dual Chamber Implantable Cardioverter Defibrillators (ICDs) sold in Canada. They are being recalled because they may lose high voltage and anti-tachycardia pacing therapy as the battery nears the end of its life. This could lead to a loss of critical heart therapy.
What to do
- Stop using the product immediately.
- Check model numbers D154ATG, D153ATG, and D154VRC.
- Contact your healthcare provider for further instructions.
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Affected products
ENTRUST DUAL CHMBR. IMPL. DEFIB. - W/ARTER. & VENTRIC. THER. & RAPID TELEM.
Model: D154ATG
Lot: All lots
ENTRUST DUAL CHMBR. CARDIOVERTER DEFIB. W/ATRIA & VENT. THER. & RAPID TELEM
Model: D153ATG
Lot: All lots
ENTRUST DUAL CHMBR. IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
Model: D154VRC
Lot: All lots
Why this matters
Loss of therapy
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: D153ATG, D154ATG, D154VRC
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?
Loss of therapy
What should consumers do?
Stop using the product immediately. Check model numbers D154ATG, D153ATG, and D154VRC. Contact your healthcare provider for further instructions.
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. Loss of therapy
When was this product recalled?
This product was recalled on July 5, 2018.
Is the Medtronic brand affected by this recall?
Yes, Medtronic products are affected by this recall. This recall involves Medtronic's EnTrust Dual Chamber Implantable Cardioverter Defibrillators (ICDs) sold in Canada. They are being recalled because they may lose high voltage and anti-tachycardia pacing therapy as the battery nears the end of its life. This could lead to a loss of critical heart therapy.