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St. Jude Medical/Controversies

St. Jude Medical controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2014Pacemaker cybersecurity vulnerability
  2. 2013FDA warning concerning Sylmar facility processes
  3. 2010Riata and Riata ST lead insulation concerns

  1. 2014

    Pacemaker cybersecurity vulnerability

    MedSec Holdings reported a security vulnerability involving St. Jude Medical pacemakers, and the FDA confirmed the vulnerability. The matter contributed to wider scrutiny of cybersecurity protections for connected implantable medical devices.

    Source

  2. 2013

    FDA warning concerning Sylmar facility processes

    The FDA sent St. Jude Medical a warning letter following inspections of its Sylmar, California facility. The cited concerns related to company processes and were not identified as safety concerns involving St. Jude Medical products.

    Source

  3. 2010

    Riata and Riata ST lead insulation concerns

    St. Jude Medical voluntarily stopped selling the Riata and Riata ST defibrillator leads after concerns that the leads could experience insulation abrasion. The FDA issued a recall in 2011. A later independent analysis reported a high rate of freedom from insulation abrasion in the evaluated Durata and Riata ST data, but the episode remained a significant product-safety and regulatory issue for the company.

    Source