Tag Archives: Class I Recall

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Sleep Aids Can Increase Alzheimer’s Risk

A new study has found that over-the-counter sleeping aids and anti-allergy medicines can increase the risk of Alzheimer’s disease.

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New York Property Owners Challenge Binghamton Fracking Ban

According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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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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Research Suggest Fracking Chemicals Can Pollute Aquifers

A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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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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