5 recent medical device safety warnings

Medical devicemakers are required to report any potential safety risks associated with their products. 

Five safety warnings issued by devicemakers and the FDA in the last few months:  

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 

More articles on supply chain:
How Cleveland Clinic manages its medical waste
Stryker warns some defibrillators may not deliver shock
FDA warning letters to devicemakers down nearly 90 percent

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months