Tag Archives: Class I Recall

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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Cancer Groups Call for E-cigarettes Regulation/Research

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects. These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make ...

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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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Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries

Patients receiving hip replacement devices or knee implants may face a more complicated recovery if they are obese, or suffer from diabetes or other health woes. According to a new study published online in the journal Anesthesiology, at least 3% of all total hip or knee replacement patients will ...

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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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St. Jude Medical Recalls Defibrillator Leads Due to Damaged Insulation

defibrillator-implant

On January 22, 2016, device maker St. Jude Medical announced that a voluntary global field safety action related for the company’s Optisure Dual Coil Defibrillation Leads has now been designated a Class 1 advisory by the Food and Drug Administration … Continue reading

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Class I Recall Issued for Brainlab Cranial IGS System

Brainlab

The U.S. Food and Drug Administration (FDA) has puts its most serious Class I label on a recall of Brainlab’s Image-Guided Surgery (IGS) System. According to an FDA recall notification, the system was recalled due to potential inaccuracy. Class I … Continue reading

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HeartWare Issues Updates to Recall Information for Ventricular Assist System

HeartWare to Recall Ventricular Assist System

Device maker HeartWare has issued updated information on the multiple recalls for its Ventricular Assist Device (HVAD). The recalls were the result of five different types of complaints from users and doctors. The update provides information on proper performance and … Continue reading

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Change in Packaging Caused Class I Recall of Peripheral Vascular Patch, Baxter Says

Packaging Caused Class I Recall of Peripheral Vascular Patch

A change in packaging caused a Class I recall of Baxter’s Vascu-Guard peripheral patch. The recall, which was initiated on May 2, 2015, affects the following four models of the Vascu-Guard Peripheral Vascular Patch: VASCU-GUARD TS 1x6cm (Product Code: 1504026), … Continue reading

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FDA Class I Recall for TigerPaw II Heart Device

FDA Class I Recall for TigerPaw II Heart Device

On May 7, 2015, the U.S. Food and Drug Administration (FDA) announced the recall of the TigerPaw System II by Maquet Medical Systems. The TigerPaw II is an implantable left atrial appendage (LAA) occlusion device meant for use during heart … Continue reading

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More than 12,000 GE MRI Systems Recalled Due to Potentially Life-Threatening Issue

More than 12,000 GE MRI Systems Recalled

A Class I recall has been issued for more than 12,000 MRI systems manufactured by General Electric, Modern Healthcare reports. The recall was issued because of a potentially life-threatening problem that can occur when parts are not connected properly. Many … Continue reading

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Class I recall issued on PEEK Ardis Inserter device used in spinal surgery; sales of accompanying system halted

Federal health regulators have issued their most serious warning about a medical device used during spinal surgery, the PEEK Ardis Inserter. According to a statement from the Food and Drug Administration, the agency has deemed a callback on the Zimmer … Continue reading

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B. Braun Recalls Infusion System

B. Braun < "http://www.yourlawyer.com/practice_areas/defective_medical_devices">Outlook 400ES Safety Infusion System, Model Number 621-400ES has been recalled in what the U.S. Food and Drug Administration (FDA) is listing as a Class I Recall. According to the FDA, the hardware in the defective medical … Continue reading

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