Category Archives: Recalled Medical Devices

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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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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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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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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Geodon the antipsychotic drug can Cause Deadly Skin Reaction

Geodon can Cause Deadly Skin Reaction, FDA Warns

The FDA has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction.

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Faulty St. Jude Riata Defibrillators may have Fatal Consequences

Patients who still have recalled St. Jude Defibrillators leads in their chests have many reasons to be vigilant. Premature insulation failure in the recalled device has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that leads to … Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls, Recalled Medical Devices, St. Jude Defibrillators |

Cook Medical Recalls Medical Device due to Blood Clot Risk

The U.S. Food and Drug Administration (FDA) has identified the Cook Medical Zenith Alpha Thoracic Endovascular Graft as a Class I recall, the most serious type of recall where there is a “reasonable probability that the use of or exposure … Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns, Legal News, Product Recalls, Recalled Medical Devices |

Mixed Metals are Focus of Stryker LFIT V40 Hip Implant Litigation

The Stryker Corporation is facing parallel litigations in Boston and New Jersey defending its LFIT Anatomic CoCr V40 Femoral Head (Cobalt Chromium V40) with allegations that the metal-on-metal ball and joint hip implant has a design defect causing it to … Continue reading

Posted in Defective Medical Devices, Depuy, Health Concerns, Metal Hip Implants, Recalled Medical Devices |

St. Jude ICD Recall Is Deemed a Class I by Federal Regulators

St. Jude ICD Recall Is Deemed a Class I

St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. Food and Drug Administration (FDA) and St. Jude issued an … Continue reading

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Teleflex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Use

Teleflex Medical Recalls Tracheostomy Tube Set

Teleflex Medical has issued a recall for the Willy Rusch Tracheostomy Tube Set because the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, the … Continue reading

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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

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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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Power Morcellators, Essure Birth Control System Prompt Introduction of Two Proposed Bills to Protect Consumers

House legislation has recently been introduced in an effort to prompt quicker action by federal regulators to remove dangerous medical devices from the market. Two bipartisan bills are expected to ease the process for patients who have suffered due to … Continue reading

Posted in Defective Medical Devices, Essure, Legal News, Product Recalls, Recalled Medical Devices |

Medtronic Recall for Respiratory Monitoring Battery Pack

A worldwide voluntary recall for the battery pack used in Medtronic’s Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitor is being conducted due to a manufacturing defect that may increase the thermal damage in the battery pack. Battery … Continue reading

Posted in Defective Medical Devices, Recalled Medical Devices |

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