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Medtronic Initiates Class I Recall For ICDs Due To Manufacturing Error

 
• By Reed Miller

Medtronic is recalling certain ICDs and CRT-Ds due to a manufacturing defect that causes a gas mixture inside the device that could prevent the device from delivering necessary electrical shocks, US FDA announced Feb. 26.

Product recall
Medtronic is recalling certain ICDs and CRT-Ds due to a manufacturing defect • Source: shutterstock.com

FDA has classified Medtronic PLC's recent urgent medical device recall notice for certain implantable cardioverter defibrillators, including some resynchronization defibrillators (CRT-D), as a Class I recall due to the potential for serious injury or death.

On Jan. 22, Medtronic sent an urgent device recall notice to customers 48 ICD and CRT-D units made between July 13, 2017 and Aug 8 2017, bearing product codes NIK, LWS

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