Medical Device Claims Archives - Page 12 of 20

FDA Makes Public Previously Hidden Database Of Millions Of Reports Of Malfunctioning Medical Devices

July 1, 2019

In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions, now making all reports received under ASR exemptions from 1999 to 2019 available. The extensive database of ASR incident reports regarding medical device malfunctions was previously [...]

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[...]

Pennsylvania Appellate Court Affirms $13.5M Mesh Verdict Against Ethicon

April 22, 2019

In its opinion filed on April 11, 2019, the Superior Court of Pennsylvania (“Pennsylvania Appellate Court”) affirmed a Pennsylvania jury’s verdict in the amount of $13,500,000.00 against Ethicon, Inc. and Ethicon’s parent company, Johnson & Johnson (collectively “Ethicon�[...]

FDA Issues Safety Communication Regarding Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors

April 4, 2019

The FDA issued a Safety Communication on March 21, 2019 entitled “Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors” “to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless[...]

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[...]

Are Filshie Clips Safe?

February 24, 2019

Millions of women in the United States have had Filshie Clips implanted as a means of permanent sterilization. The vast majority of these women apparently have not suffered any complications or adverse events regarding their Filshie Clips. Nonetheless, we receive inquiries on nearly a daily basis fr[...]

Essure No Longer Sold In U.S. After December 31, 2018, But FDA Oversight Continues

February 8, 2019

In July 2018, Bayer, which manufactures the Essure device that is intended to prevent pregnancy, announced that Essure will no longer be sold or distributed in the United States after December 31, 2018, citing the declining annual number of implantations. Even though Essure is no longer sold, the FD[...]

Medtronic Issues Urgent Recall Of Nearly 157,000 Dual Chamber Pacemakers

February 2, 2019

Medtronic has issued an “Urgent Medical Device Recall” voluntarily recalling and suspending distribution of a subset of Medtronic dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta; Versa; and Sensia. The affected medical[...]

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[...]

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Category: Medical Device Claims