Category Archives: Recalled Medical Devices

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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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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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Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

81-year-old Port Jefferson Station man was killed in a crash at 4:57 a.m.. He lost control of the vehicle traveling west on Northern State Pkwy, on exit 42, Dix Hills.

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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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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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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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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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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