St Jude Medical Quickflex Recall

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. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and …

Cardiovascular Product Advisories | Abbott

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

An urgent medical device recall notice communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did …

Cardiovascular Product Advisories | Abbott

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

Important Medical Device Recall: HeartMate 3 Modular Cables with LVAS Controller Important Information – December 20, 2019 ... QuickSite and QuickFlex LV CRT Leads …

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 Medical Defibrillators - Devices at Risk, Recalls

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

St. Jude Medical Recalls Implantable Defibrillators. In October 2016, St. Jude Medical issued a recall of 251,346 ICD and CRT-D devices in the …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&pnumber=P880086

FDA Recall Posting Date. ... 2 08/02/2022 St. Jude Medical, Cardiac Rhythm Management Division Merlin PCS 3650 programmer Model 3330 software: 2 08/02/2022 …

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 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

Thursday, July 8, 2021. St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 …

St. Jude Defibrillator Lead Problems: Riata, QuickSite, …

https://www.youhavealawyer.com/blog/2012/08/17/st-jude-lead-problems/

As a result of design and manufacturing defects, a St. Jude defibrillator lead recall was issued last year for the Riata and Riata ST leads. The recall came after St. …

St. Jude pulls problematic pacemaker wires - Star Tribune

https://www.startribune.com/st-jude-pulls-problematic-pacemaker-wires/146089315/

St. Jude Medical Inc. will stop selling its QuickSite and QuickFlex heart pacemaker connecting wires, called leads, after 39 reports of wires protruding through …