St Jude Medical Device Recall

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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

Abbott (formally known as “St. Jude Medical”) is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment, that were then distributed from April 2015 to February 2019. A small number of devices from that time frame have experienced problems when moisture is able to get insi… See more

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 Defibrillators - Devices at Risk, …

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 …

ICD and CRT-D Battery Advisory | Abbott

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

OCTOBER 2016 GLOBAL MEDICAL ADVISORY CONCERNING SUBSET OF ICD AND CRT-D DEVICES WHAT YOU NEED TO KNOW. St. Jude Medical announced a global medical device …

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. …

Cardiovascular Product Advisories | Abbott

https://www.cardiovascular.abbott/us/en/hcp/product-advisories.html

An urgent medical device recall notice to hospitals, clinics and patients communicating that a small number of CardioMEMS Hospital Electronics Systems Model CM3000 and …

St. Jude Medical Pays $27 Million for Allegedly Selling …

https://www.dicardiology.com/content/st-jude-medical-pays-27-million-allegedly-selling-defective-heart-devices

July 28, 2021 — The U.S. Justice Department announced earlier this month that St. Jude Medical Inc. agreed to pay $27 million to settle allegations under the False …

St. Jude Medical Played Down Defibrillator …

https://www.nytimes.com/2017/04/13/health/st-jude-medical-defibrillator-abbot-fda.html

The medical device maker St. Jude Medical played down the failure of some batteries in its defibrillators, shipping them for years before recalling the devices last fall, according to a...

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, Inc. (St. Jude) …

MAUDE Adverse Event Report: ST. JUDE MEDICAL, …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=11904812&pc=LWR

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