St Jude Medical Lead Recalls

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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

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: …

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. …

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 …

St. Jude Durata Lead Issues | Durata Lead Failure

https://www.classaction.org/durata-leads

Date. In Oct. 2012, the FDA conducted an inspection of a St. Jude manufacturing plant in California, finding 11 problems related to the design and …

Class 2 Device Recall QuickFlex, QuickFlex XL

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=108651

A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. …

Riata Defibrillation Leads Communications | Abbott

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

We voluntarily and proactively stopped selling our Riata™ and Riata ST Silicone Defibrillation Leads in December 2010. We have communicated to physicians …

FDA Recalls 60,000 Abbott Pacemakers Due to Defect

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

The pacemaker manufacturer was formerly known as St. Jude Medical before merging with Abbott in January 2017. The electrical shorts that triggered the recall …

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 …

Hacking risk leads to recall of 500,000 …

https://www.theguardian.com/technology/2017/aug/31/hacking-risk-recall-pacemakers-patient-death-fears-fda-firmware-update

Six types of pacemaker, all made by healthtech firm Abbott and sold under the St Jude Medical brand, are affected by the recall. They are all radio-controlled implantable cardiac...

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