Tag Archives: Medtronic

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

E. District of Missouri denied motion to dismiss conspiracy claims. Lawsuit alleges the defendants conspired to misrepresent true dangers with use of talcum powder.

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Long Island Car Crash Kills 1 Person, Injures 2 More

Long Island Car Crash Kills 1 Person, Injures 2 More

A car accident on LI left one person dead & two more critically injured. The crash occurred Monday in Deer Park on Straight Path, south of Sagamore Lane.

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

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Catheter Recalls due to Serious Complications and Injuries

Catheter Recalls due to Serious Complications and Injuries

The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing … Continue reading

Posted in Defective Medical Devices | Tagged , , , , |

HeartWare International Heart Pump Subject to FDA Class 1 Recall

HeartWare International Heart Pump Subject to FDA Recall

Medtronic has announced that the U.S. Food and Drug Administration (FDA) has classified two global voluntary recalls of HeartWare International’s HeartWare Ventricular Assist Device (HVAD) as Class 1 recalls. A class 1 recall is the FDA’s most serious recall category, … Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices | Tagged , , , , |

Deep Brain Stimulation Rechargers May Fail to Charge, Medtronic Warns

Deep Brain Stimulation Rechargers May Fail to Charge

In an October 2016 “Urgent Field Safety Notice”, Medtronic warned that some rechargers for its deep brain stimulation devices may be prone to an “error state” and fail to charge. According to the letter, some of its Model 37751 rechargers … Continue reading

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Medtronic Recalls Thousands of Lots of Various Neurovascular Products

Medtronic Recalls Lots of Various Neurovascular Products

Medtronic PLC just recalled certain lots of four of its neurovascular products. The device maker noted that the recalled devices might lead to a thromboembolic event (blood clot) in patients. The recalled Medtronic neurovascular products are: Pipeline Embolization Device (1742 … Continue reading

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Medtronic Recalls Temporary Cardiac Lead Pacing Systems

Medtronic Recalls Temporary Cardiac Lead Pacing Systems

The Food and Drug Administration (FDA) has announced a Class II designation for a recall involving thousands of Medtronic temporary lead pacing systems because there is the potential for them to connect to a hazardous voltage. The recall involves 11,697 of … Continue reading

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Medtronic Issues Warning for Heart Valve Delivery System

Medtronic Issues Warning for Heart Valve Delivery System

Medtronic PLC has issued a warning regarding its minimally invasive EnVeo R delivery system, which is used to implant the Evolut R aortic valve in the heart. The company is urging doctors to take extra precautions when inserting the device, … Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , , |

Medtronic Uses Preemption in Medtronic Infuse Case, Again

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , , , , |

Medtronic Pays $500 Million Tax Charge To Move $9.8 Billion To United States

Medtronic Pays $500M Tax Charge To Move $9.8B To U.S.

As part of an internal restructuring related to its $49.9 billion merger with Covidien, Medtronic will pay a one-time tax charge of $500 million so that it can bring $9.8 billion in overseas cash to the United States. This move … Continue reading

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Newly Approved Medtronic Heart Device Component Under Recall

Medtronic's Heart Device Component Under Recall

Just weeks after receiving Food and Drug Administration (FDA) approval, Medtronic’s EnVeo R Loading System, used with the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), has been recalled. Medtronic said it had received eight reports of the … Continue reading

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European Regulators Review Medtronic’s InductOs in Light of Contamination Issues

European Regulators Review Medtronic’s InductOs

The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the … Continue reading

Posted in Legal News, Medtonic Infuse | Tagged , , , |

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