Carelink Programmer System (2019-10-04)
In plain language
This recall involves the Medtronic Carelink Programmer System and related implanted cardiac devices sold in Canada. It's being recalled because the programmer and remote monitoring software may display an inaccurate remaining battery life estimate for some devices. The issue does not affect device functionality, and the recommended replacement time (RRT) remains accurate. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Contact Medtronic Inc. for more information.
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Affected products
Carelink programmer
Model: 2090
Lot: More than 10 numbers, contact manufacturer.
Carelink - Device Data Management Software
Model: 2491
Lot: More than 10 numbers, contact manufacturer.
Viva XT CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
Model: DTBA2D1
Lot: More than 10 numbers, contact manufacturer.
Viva Quad XT CRT-D
Model: DTBA2Q1
Lot: More than 10 numbers, contact manufacturer.
Evera XT DR Digital Dual Chamber Implantable Cardioverter Defibrillator
Model: DDBB2D1
Lot: More than 10 numbers, contact manufacturer.
Evera S DR Digital Dual Chamber Implantable Cardioverter Defibrillator
Model: DDBC3D1 DDBC3D4
Lot: More than 10 numbers, contact manufacturer.
Evera XT VR Digital Single Chamber Implantable Cardioverter Defibrillator
Model: DVBB2D1
Lot: More than 10 numbers, contact manufacturer.
Evera S VR Digital Single Chamber Implantable Cardioverter Defibrillator
Model: DVBC3D1 DVBC3D4
Lot: More than 10 numbers, contact manufacturer.
Brava Quad CRT-D
Model: DTBC2QQ
Lot: BLX613576S BLX613625S BLX613724S BLX613902S BLX613904S BLX613905S BLX613908S BLX613932S BLX614052S
Evera MRI XT DR Surescan
Model: DDMB2D1 DDMB2D4
Lot: More than 10 numbers, contact manufacturer.
Evera MRI XT VR Surescan
Model: DVMB2D1 DVMB2D4
Lot: More than 10 numbers, contact manufacturer.
Evera MRI S DR Surescan
Model: DDMC3D1 DDMC3D4
Lot: More than 10 numbers, contact manufacturer.
Evera MRI S VR Surescan
Model: DVMC3D4
Lot: PMZ621884S PMZ621903S PMZ621929S PMZ621930S PMZ621931S
Micra MC1VR01
Model: MC1VR01
Lot: More than 10 numbers, contact manufacturer.
Amplia MRI CRT-D Surescan
Model: DTMB2D1 DTMB2D4
Lot: More than 10 numbers, contact manufacturer.
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: BLX613576S BLX613625S BLX613724S BLX613902S BLX613904S BLX613905S BLX613908S BLX613932S BLX614052S, More than 10 numbers, contact manufacturer., PMZ621884S PMZ621903S PMZ621929S PMZ621930S PMZ621931S
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 2090, 2491, DDBB2D1, DDBC3D1 DDBC3D4, DDMB2D1 DDMB2D4, DDMC3D1 DDMC3D4, DTBA2D1, DTBA2Q1, DTBC2QQ, DTMB2D1 DTMB2D4, DVBB2D1, DVBC3D1 DVBC3D4, DVMB2D1 DVMB2D4, DVMC3D4, 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?
This recall involves the Medtronic Carelink Programmer System and related implanted cardiac devices sold in Canada. It's being recalled because the programmer and remote monitoring software may display an inaccurate remaining battery life estimate for some devices. The issue does not affect device functionality, and the recommended replacement time (RRT) remains accurate. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Contact Medtronic Inc. for more information.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on November 1, 2019.
Is the Medtronic brand affected by this recall?
Yes, Medtronic products are affected by this recall. This recall involves the Medtronic Carelink Programmer System and related implanted cardiac devices sold in Canada. It's being recalled because the programmer and remote monitoring software may display an inaccurate remaining battery life estimate for some devices. The issue does not affect device functionality, and the recommended replacement time (RRT) remains accurate. Stop using the product and follow the return/repair steps in the official notice.