Monday, March 27, 2017
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Medical Devices

CareFusion Ventilator Recall

Medical device manufacturer CareFusion is recalling the AVEA ventilators due to a defect that may cause ventilators to unexpectedly shut down. A faulty fuse in the alarm board could cause the machine to turn off without a warning alarm. Ventilator shut-down can lead to serious health consequences or death. CareFusion sent letters on May 17, 2016 to notify buyers of ... Read More »

HeartWare(HVAD) Battery Recall

Heartware Ventricular Assist Device Batteries Recalled.

HeartWare Inc. has issued a nationwide recall of batteries for their HeartWare ventricular assist device (HVAD) because they may lose power prematurely. The HVAD is a machine used to assist the heart in delivering blood in patients at risk of heart failure. It consists of a pump implanted near the heart and a controller that regulates the speed and function ... Read More »

Cook Medical Recalls 4.1 Million Catheters

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Approximately 4.1 million catheters have been recalled by Cook Medical after 30 medical device reports were received by the FDA’s MedWatch reporting program. Reports indicated that the tip of the catheters can fracture or separate during a procedure. The recall is one of the largest by Cook Medical in years, expanding on previous recalls from 2015. They have had many ... Read More »

Essure Birth Control Device Linked to Serious Side Effects, Deaths

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The Food and Drug Administration (FDA) is reviewing the permanent birth control device Essure after thousands of reports of adverse events including the death of four women and five fetuses. U.S. Rep Rosa DeLauro spoke out against Essure, saying she was “deeply disturbed by reports from women about severe adverse health effects they have suffered …” and called for Essure ... Read More »

Power Morcellator Warning Drives Hysterectomy Doctors Towards New Methods

Lexapro

Months ago the FDA released an update to the power morcellator warning and now a majority of physicians have changed their clinical practice as a result. The minimally invasive procedure has been known to spread undetected cancer cells during the removal of uterine fibroids, turning doctors towards other surgical methods. The spread of these cancer cells cause an increased risk of ... Read More »

Transvaginal Mesh Trial Tells Boston Scientific To Pay $100 Million To Injured Woman

Boston Scientific has been instructed to pay out $100 Million to a woman who was injured by the transvaginal mesh product.

Boston Scientific Loses Another Trial Against Transvaginal Mesh Product On Thursday, Boston Scientific was ordered to pay a woman $100 million after being injured by transvaginal mesh. This medical device is subject to over 25,000 lawsuits. The transvaginal mesh settlement awarded to the woman included $25 million in compensatory damages, as well as $75 million in punitive damages. This is ... Read More »

FDA Warns Tanners About The Dangers of Indoor Tanning

The FDA has published new rules, classifying indoor tanning beds as a class II medical device.

  One year ago the Food and Drug Administration began regulating indoor tanning equipment as class II medical devices, requiring them to have black box warnings that tanning devices should not be used by those under the age of 18. Due to research providing evidence of the risks of skin cancer and health problems associated with the use of tanning ... Read More »

Zimmer Inc. Recalls Persona Metal Tibial

Arthritis

Zimmer Inc. is issuing a recall on approximately 11,658 units of the Persona Trabecular Metal Tibial after an increase of complaints of loosening and radiolucent lines. All sizes of the products are being removed from distribution, and an Urgent Medical Device Recall notice was issued to affected distributors, hospitals, and surgeons. Customers have been asked to review the notification and ... Read More »

HeartWare Inc. Issues An Urgent Medical Device Correction Letter

HeartWare Inc. has issued an Urgent Medical Device Correction letter to all affected consignees on May 11, 2015. The product recalled is the HeartWare Ventricular Assist System Pump Driveline Splice Kit due to failure of the splice repair kit if exposed to excessive force. A repair will be made once an electrical break is identified. The repairs needed are limited ... Read More »

Johnson & Johnson Resolves First Vaginal Mesh Cases, Denies Wrongdoing

Boston Scientific has been instructed to pay out $100 Million to a woman who was injured by the transvaginal mesh product.

Johnson & Johnson (J&J), facing over 23,000 lawsuits from women who have been injured by their vaginal mesh implants, has agreed to settle its first four transvaginal mesh cases. Until now, J&J has stayed on the sidelines as other vaginal mesh implant manufacturers have worked on a settlement with attorneys representing women injured by the implants. The women suing J&J ... Read More »