medical device lawyers Archives - Page 2 of 3

9.1M Surgical Gowns Recalled

February 13, 2020

On January 21, 2020, “Cardinal Health informed customers of a voluntary recall for the surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law, were not r[...]

Alaris™ Pump Modules Model 8100 Recalls

September 22, 2019

In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type of plastic material. BD condu[...]

Kaiser Health News Reports On FDA’s “Hidden” Database Of Malfunctions Of Medical Devices

July 2, 2019

Kaiser Health News reported on June 27, 2019 that its investigation found that “[medical] device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database [alternative summary reporting database], bypassing the public FDA databas[...]

FDA Issues Safety Communication Regarding The Stryker Wingspan Stent System

May 15, 2019

The FDA issued a Safety Communcation on April 25, 2019 entitled, “Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication” in which the FDA warned: “a very specific group of patients, consisten[...]

FDA Orders Manufacturers Of Surgical Mesh For Pelvic Organ Prolapse To Cease Sales And Distribution

April 25, 2019

On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to immediately stop selling and distributing their products in the United States. The manufacturers, B[...]

When Will The FDA Investigate The Metal In Filshie Clips?

March 29, 2019

The FDA issued a statemnet on March 15, 2019 entitled “Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions” in whi[...]

Stryker Defibrillator Recall

March 3, 2019

On February 1, 2019, Stryker issued an “URGENT MEDICAL DEVICE SAFETY NOTICE & CORRECTION ACTION REQUIRED” regarding its LIFEPAK® 15 Monitor/Defibrillator, stating that “Stryker is conducting a voluntary Field Action for specific LIFEPAK 15 Monitor/Defibrillator devices that m[...]

Mycobacteria Chimaera Infections Associated With Heater-Cooler Unit Use During Cardiopulmonary Bypass Surgery

January 22, 2019

In December 2016, a hospital in Los Angeles County, California reported two Mycobacterium avium complex infections, later identified as Mycobacterium chimaera, in patients with a recent history ([...]

Olympus Medical Systems Corporation Pleads Guilty To Failing To Report Infections Associated With Its Duodenoscopes

December 27, 2018

The U.S. Department of Justice announced on December 10, 2018 that Olympus Medical Systems Corporation (“Olympus”), and a former senior executive in Japan, have pled guilty to failing to file required adverse event reports involving infections connected to its duodenoscopes, and to conti[...]

Defective Medical Devices Caused 1.7 Million Injuries, 83,000 Deaths In U.S.

November 29, 2018

The Implant Files, which is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all, analyzed more than 8 million device-related health records, including death and injury reports and recalls, and found “more than 1.7 million injur[...]

FDA Issues Proposed Cybersecurity Recommendations For Medical Devices

November 11, 2018

Imagine you or a loved one has an implanted medical device, such as a heart pacemaker, that may be hacked and controlled by someone other than the manufacturer or your doctor. Someone could conceivably control the device such that you or your loved may be seriously harmed (or worse). On October 17, [...]

Federal Appellate Court Allows Some State Law Claims In Medical Device Lawsuit

April 8, 2018

The United States Court of Appeals for the Third Circuit (“Federal Appellate Court”) addressed the issue of how courts should apply the federal express preemption provision to state law tort claims challenging the design and manufacture of a medical device comprised of multiple component[...]

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Tag: medical device lawyers