defective medical device Archives - Medical Malpractice Lawyers

Abiomed Recalls Automated Impella Controllers For Updated Use Instructions

October 15, 2026

Abiomed has issued an Urgent Medical Device Recall (Correction) notice to affected customers recommending updated use instructions for all Automated Impella Controllers (AIC). The Automated Impella Controller is the primary user control interface for the Impella Catheters. It controls the Impella Ca[...]

Convenience Kit Issue From Aligned Medical Solutions – Potentially Defective Syringe

September 10, 2026

Aligned Medical Solutions initiated an urgent Medical Device Recall notification for convenience kits that contain syringes affected by Medline’s Namic Angiographic Control Syringes with Rotating Adaptor (“Namic RA Syringes”) recall. Convenience kits contain various surgical instrument[...]

Kimberly-Clark Corporation Agrees To Pay Up To $40M To Resolve Criminal Charge Related To Sale Of Adulterated MicroCool Surgical Gowns

October 9, 2025

The United States Department of Justice announced on August 28, 2025 that Kimberly-Clark Corporation (Kimberly-Clark), a U.S.-based multinational consumer goods and personal care company, has agreed to pay up to $40.4 million to resolve a criminal charge relating to the company’s sale of adulterat[...]

Mobile App For Insulin Pump Recalled

May 9, 2024

Tandem Diabetes Care, Inc. is recalling version 2.7 (released February 12, 2024 on the Apple iOS platform) of the t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology by correction. The reason for the recall is due to an issue with the software that may cau[...]

Federal Appellate Court Says Jury Should Decide When Patient Should Have Been Aware Defective Medical Device Caused His Injuries

October 3, 2023

Background Facts In December 2016, Andrew Bruno had shoulder surgery to implant a prosthetic device with parts manufactured by Biomet. Two-weeks postoperation, Bruno followed-up with his surgeon, Dr. Doulens, and reported some clear drainage at the bottom of his incision. Although the doctor did not[...]

Connecticut Defective Medical Device Lawsuit Alleges Injury To CRNA When The Device Exploded Or Separated In The OR

September 8, 2023

Defective Medical Device Lawsuit Alleges Injury To CRNA When Device Exploded: A lawsuit filed on November 22, 2022 in the Superior Court in Connecticut alleges that on August 4, 2021, the Plaintiff, David White, was a certified registered nurse anesthetist (CRNA) assigned by his employer to provide [...]

FDA Issues Class I Recall Of Syringe Pumps Due To Malfunctioning Alarms

January 15, 2020

The FDA has issued a Class I recall of certain Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 manufactured by Smiths Medical ASD, Inc. because the firmware could potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the[...]

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 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, [...]

California Appellate Court Reduces Punitive Damages Award From $70M To $19.6M In Malfunctioning Surgical Stapler Case

July 8, 2018

The Court of Appeal of the State of California First Appellate District Division Five (“California Appellate Court”), in its opinion filed on June 13, 2018, reduced the punitive damages award by a California jury from $70 million to $19.7 million (i.e., two-times the amount of the compen[...]

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[...]

Are Medical Devices Vulnerable To Cyber Attacks?

October 24, 2016

Many people are implanted with medical devices every year that allows them to live longer, more active, and productive lives, which devices are controlled by computer chips that tell the devices how to function and behave. Some of these implantable medical devices help control the rhythm of the[...]

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Tag: defective medical device