Medtronic: class I recall- manufacturing error preventing electrical shock delivery

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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

 

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