St Jude Medical Defibrillator Recall

St. Jude Medical Defibrillators - Devices at Risk, Recalls

https://www.drugwatch.com/defibrillators/

In October 2016, St. Jude Medical issued a recall of 251,346 ICD and CRT-D devices in the U.S. due to premature battery depletion. A total of 841 of the 398,740 defibrillators St. Jude Medical had sold worldwide experienced premature battery depletion. This included …

FDA issues Class I recall on St. Jude's defibrillator leads

https://www.reuters.com/article/st-jude-medical-recall-idUSL2N1562IE

A Class 1 recall is the strictest form of recall issued by the health regulator, in situations where the use of faulty devices may cause serious injury or death. St. Jude …

Abbott (formally known as “St. Jude Medical”) Recalls …

https://www.fda.gov/medical-devices/medical-device-recalls/abbott-formally-known-st-jude-medical-recalls-assuritytm-and-enduritytm-pacemakers-potential

St. Jude Agrees to Pay $27 Million for Allegedly Selling …

https://www.justice.gov/opa/pr/st-jude-agrees-pay-27-million-allegedly-selling-defective-heart-devices

St. Jude Agrees to Pay $27 Million for Allegedly Selling Defective Heart Devices. St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle …

St. Jude Medical Inc. (St. Jude) has agreed to pay $27 …

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/st-jude-agrees-pay-27-million-allegedly-selling-defective-heart-devices

St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, …

St. Jude Medical Agrees to Pay $27 Million for Allegedly …

https://www.justice.gov/usao-md/pr/st-jude-medical-agrees-pay-27-million-allegedly-selling-defective-heart-devices

Company Allegedly Failed to Inform FDA of Defect in Implantable Defibrillators that Caused Injuries and Death. Baltimore, Maryland – St. Jude Medical, …

Class 1 Device Recall Riata ST Silicone Insulated Leads

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105847

818-362-6822. Manufacturer Reason. for Recall. The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause …

ICD and CRT-D Battery Advisory | Abbott

https://www.cardiovascular.abbott/us/en/patients/cardiovascular-device-patient-services/battery-advisory.html

On April 16, 2018 we released information about the availability of a planned upgrade to the firmware on a subset of implantable cardioverter defibrillator (ICD) and cardiac …

FDA Issues St. Jude Medical Defibrillator …

https://medtruth.com/articles/fda-regulation/st-jude-medical-defibrilliator-recall/

Jude Medical recommends immediate device explant and replacement.” More than 175,000 defibrillation devices have been recalled across the U.S. since they …

St. Jude to Settle Defibrillator Allegations for $27 Million

https://lopezmchugh.com/2021/07/27/st-jude-to-settle-defibrillator-allegations-for-27-million/index.html

St. Jude to Settle Defibrillator Allegations for $27 Million. “The government contends that St. Jude knowingly caused the submission of false claims and failed to …