Tag Archives: Class I Recall

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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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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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Lawsuits over DePuy ASR Metal-on-Metal Hip Implants Continue to Mount

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be hit with lawsuits over recalled metal-on-metal DePuy ASR hip implants. Just yesterday, the national law firm of Parker Waichman LLP announced it had filed yet another DePuy ASR hip implant lawsuit, this time on behalf of a Virginia resident ...

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Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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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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