St Jude Medical Riata Recall

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Class 1 Device Recall Riata ST Silicone Insulated Leads

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

St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous high voltage (HV)...

Class 1 Device Recall Riata - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105844

for Recall: St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone …

Riata Defibrillation Leads Communications | Abbott

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

The main findings include: 1) the prevalence of externalized conductors (EC) and electrical dysfunction (ED) was highest in Riata and Riata ST leads; 2) the …

St. Jude Medical's recalled Riata leads slammed (again) for …

https://www.fiercebiotech.com/medical-devices/st-jude-medical-s-recalled-riata-leads-slammed-again-for-higher-failure-rates

St. Jude Medical's recalled Riata leads slammed (again) for higher failure rates | Fierce Biotech Fierce Pharma Fierce Biotech Fierce Healthcare Fierce Life Sciences Events …

Recall: St. Jude’s Riata recall lands in Class I status

https://www.massdevice.com/recall-st-judes-riata-recall-lands-class-i-status/

The FDA slapped St. Jude Medical Inc.’s (NYSE: STJ) Riata with a Class I recall after the company said the defibrillator leads failed more frequently than previously …

Cardiovascular Product Advisories | Abbott

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

Urgent Medical Device Recall: HeartMate Coring Tool with Black Particle From Blade Cover – March 7, 2019 An urgent medical device recall notice communicating that a physician observed a small black …

Abbott’s St. Jude Medical can’t escape Riata lead lawsuit

https://www.massdevice.com/abbotts-st-jude-medical-cant-escape-riata-lead-lawsuit/

“Connelly’s complaint identifies specific facts from an internal St. Jude audit, three FDA enforcement actions, two Dear Doctor letters, and the 2011 Class I recall of the Riata Leads....

St Jude Medical Riata Implantable Defibrillator Leads

https://medsafe.govt.nz/hot/RecallActionNoticesNew/StJudeMedicalRiataImplantableDefibrillatorLeads.asp

St Jude Medical have issued a letter to surgeons and cardiac technicians to inform them of this alert and to advise them to contact all patients who have Riata and …

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

Reason for Recall Abbott (formally known as “St. Jude Medical”) is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing …

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 …

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