Five safety warnings issued by devicemakers and the FDA in the last few months:
- Stryker warns some defibrillators may not deliver shock
Stryker said in a Jan. 10 safety warning that some of its Lifepaks failed to deliver a defibrillator shock after the “shock” button was pressed. - Medtronic files safety warning in UK over robotic system
Medtronic warned healthcare providers that a piece of its Mazor X surgical system may release unexpectedly from the operating table. - Abbott warns of 2 potential safety issues with its heart implant
Abbott warned that connecting the modular cable to the HeartMate 3 at the wrong angle when exchanging controllers can stop electrical power from reaching the pump, which can cause serious injury or death. - Medtronic warns of insulin pump potential safety risk
Medtronic said its MiniMed 620G, 630G, 640G and 670G insulin pumps may deliver too much or too little insulin if a component on the pump called the retainer ring becomes damaged from accidental dropping or bumping against a hard surface. - FDA warns of blood leak risk with Endologix endografts
The FDA said there may be a higher than expected risk of blood continuing to leak into the aneurysm sac, known as a Type III endoleak, with the use of Endologix’s AFX with Duraply and AFX2 endovascular grafts.
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Stryker warns some defibrillators may not deliver shock
FDA warning letters to devicemakers down nearly 90 percent
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