The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product(s): Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs)
- Product Codes: NIK, LWS
- Serial Numbers: See Complete List
- Manufacturing Dates: July 13, 2013 to August 8, 2017
- Devices Recalled in the U.S.: 48 units nationwide
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
Reason for Recall
Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.
The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.
Who is affected?
- Patients with an affected Medtronic ICD or CRT-D device
- Caregivers of patients with an affected Medtronic ICD or CRT-D device
- Health care providers treating patients with heart failure or heart rhythm problems using affected Medtronic ICD or CRT-D devices
What to Do:
On January 22 2018 Medtronic sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to:
- Consider Prophylactic device replacement for patients who have been implanted with one of the affected devices.
- Contact their Medtronic sales representative for terms and conditions for device warranties.
- Review the recall notice and ensure appropriate staff is aware of the notice.
Medtronic will offer a supplemental device warranty for affected devices.
Customers who have questions or need additional information or support regarding this recall should contact their local Medtronic sales representative or Medtronic Technical Services at 800-723-4636.
Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).
Date Recall InitiatedJanuary 22, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
|Cardiac Resynchronization Therapy
with Defibrillation (CRT-Ds)
|Device Model||Device Serial
|Amplia MRI CRT-D DF4||DTMB1D4||RPJ201956H|
|Amplia MRI Quad CRT-D DF4||DTMB1QQ||RPE201417H
|Claria MRI Quad CRT-D DF4||DTMA1QQ||RPA204495H|
|Compia MRI Quad CRT-D DF4||DTMC1QQ||RPL201034H|
|Viva Quad S CRT-D DF4||DTBB1QQ||BLK204122H|
|Viva Quad XT CRT-D DF4||DTBA1QQ||BLC224272H
|Viva S CRT-D DF1||DTBB1D1||BLO204984H|
|Viva XT CRT- D DF1||DTBA1D1||BLF216780H
|Viva XT CRT- D DF4||DTBA1D4||BLE220200H|
|Device Model||Device Serial
|Evera MRI XT DR ICD DF1||DDMB1D1||CWA200012H
|Evera MRI XT DR ICD DF4||DDMB1D4||PFZ214605H
|Evera MRI XT VR ICD DF4||DVMB1D4||PKZ203327H
|Evera MRI S DR ICD DF1||DDMC3D1||CWC200055H|
|Evera S DR ICD DF1||DDBC3D1||BWG204574H|
|Evera S VR ICD DF1||DVBC3D1||BWM204635H|
|Evera XT DR ICD DF1||DDBB1D1||BWC223253H
|Evera XT VR ICD DF1||DVBB1D1||BWI208876H|
|Evera XT VR ICD DF4||DVBB1D4||BWH201158H
|Visia AF MRI VR SureScan ICD DF1||DVFB1D1||CWG200402H|
|Visia AF MRI VR SureScan ICD DF4||DVFB1D4||PKX202448H
|Visia AF VR ICD DF1||DVAB1D1||BWN201126H|