St Jude Medical is a leading manufacturer of medical devices and implants, including cardiac devices, neurostimulators, and surgical tools. Their products are used in various medical procedures and treatments.
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
St Jude Medical is a prominent company in the medical device industry, specializing in cardiac devices, neurostimulators, and surgical tools. They produce a wide range of products for various medical procedures and treatments.
Low risk due to the company's focus on medical device safety and regulatory compliance. St Jude Medical follows strict quality control and safety standards to ensure their products are safe for use.
Patients, healthcare professionals, and medical facilities
Check for proper labeling, regulatory approvals (e.g., FDA), and adherence to safety standards. Ensure the device is used by trained medical professionals.
Ensure the device has the appropriate regulatory approvals, such as FDA clearance or CE marking, before use.
Look for clear labeling that includes the device name, model number, manufacturer information, and any necessary warnings or instructions.
Only trained medical professionals should use St Jude Medical devices to ensure safe and effective application.
St Jude Medical produces cardiac devices, neurostimulators, surgical tools, and other medical implants.
Yes, St Jude Medical devices undergo rigorous testing and quality control to ensure safety and effectiveness. They comply with strict regulatory standards.
Check for proper labeling, regulatory approvals (e.g., FDA), and purchase through authorized channels.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2328-2018 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2328-2018 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
