St Jude Medical 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 … 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 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 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 …

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 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) …

FDA Recalls 60,000 Abbott Pacemakers Due to Defect

https://www.aarp.org/health/conditions-treatments/info-2021/fda-recalls-abbott-pacemakers.html

The FDA, which has received 135 reports of injuries, identified the recall as a Class I, its most serious type, because of the risk of serious injury or death. If …

ICD and CRT-D Battery Advisory | Abbott

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

St. Jude Medical announced a global medical device advisory for a subset of our company’s Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ implantable cardiac defibrillator (ICD) …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=78093

St Jude Medical Inc. Z-0038-2018 - PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable …

Class 2 Device Recall Accent DR - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104490

Medical Device Recalls | FDA

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

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …

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