Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (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.
- Product Codes: NIK, LWS
- Serial Numbers: See Complete List in Recall Notice
- Manufacturing Dates: July 13, 2013 to August 8, 2017
- Devices Recalled in the U.S.: 48 units nationwide
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.
Complete list of serial numbers
| CRT-Ds | Device model | Device serial number |
| Amplia MRI CRT-D DF4 | DTMB1D4 | RPJ201956H |
| Amplia MRI Quad CRT-D DF4 | DTMB1QQ | RPE201417H RPE204789H RPE206207H RPE207850H RPE209095H RPE212027H |
| 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 BLC227175H BLC227641H |
| Viva S CRT-D DF1 | DTBB1D1 | BLO204984H |
| Viva XT CRT- D DF1 | DTBA1D1 | BLF216780H BLF231229H BLF250740H BLF251155H BLF255165H |
| Viva XT CRT- D DF4 | DTBA1D4 | BLE220200H |
| ICDs | Device model | Device serial number |
| Evera MRI XT DR ICD DF1 | DDMB1D1 | CWA200012H CWA202259H CWA203498H |
| Evera MRI XT DR ICD DF4 | DDMB1D4 | PFZ214605H PFZ228504H PFZ228590H PFZ228836H PFZ228838H PFZ229236H |
| Evera MRI XT VR ICD DF4 | DVMB1D4 | PKZ203327H PKZ210673H |
| 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 BWC233374H BWC234767H BWC234772H |
| Evera XT VR ICD DF1 | DVBB1D1 | BWI208876H |
| Evera XT VR ICD DF4 | DVBB1D4 | BWH201158H BWH214640H |
| Visia AF MRI VR SureScan ICD DF1 | DVFB1D1 | CWG200402H |
| Visia AF MRI VR SureScan ICD DF4 | DVFB1D4 | PKX202448H PKX205417H PKX205779H PKX209277H PKX212710H |
| Visia AF VR ICD DF1 | DVAB1D1 | BWN201126H |
