Medtronic recall of ICD, CRT-D devices designated class I
Click Here to Manage Email Alerts
Key takeaways:
- Medtronic recalled ICDs and CRT-Ds with a glassed feedthrough made after Oct. 13, 2017 due to risk for low- or no-energy shocks when needed.
- The FDA has identified the recall as class I, the most serious type.
Medtronic announced a recall of all implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillators manufactured after Oct. 13, 2017 with a glassed feedthrough.
Due to inappropriate activation of the short circuit protection feature, the affected devices (Cobalt XT, Cobalt and Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds; Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs) may deliver low or no energy output when therapy is needed, according to an alert from the FDA.
Image: Adobe Stock
The FDA has identified the recall as class I, the most serious type of recall, as use of these devices may fail to prevent cardiac arrest, other serious injuries or death.
Inappropriate activation of the short circuit protection feature is more likely in devices with a glassed feedthrough configured to deliver therapy in the AX>B delivered pathway, according to the release.
Among 348,616 recalled devices, the company reported 28 incidents, 22 injuries and no deaths related to this issue, the FDA stated in the alert.
Medtronic sent the following statement by email to Healio:
“In May 2023, Medtronic began informing physicians of a potential risk for reduced-energy or no-energy high-voltage therapy in its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured after July 2017. Medtronic provided physicians with comprehensive patient management recommendations in the communication. We have recommended that physicians non-invasively reprogram these devices to reduce the risk for this issue. The FDA recently designated this voluntary action by Medtronic as a Class I recall. There have been no reports of permanent patient harm or deaths due to this issue in the affected population.”
Click Here to Manage Email Alerts