medical device claim Archives - Medical Malpractice Lawyers

Boston Scientific Recalls Vascular Stent Due To Risk Of Resistance During Device Withdrawal

October 12, 2025

The Carotid WALLSTENT Monorail Endoprosthesis is a self-expanding stent used to open narrowed carotid arteries and is placed using a catheter over a guidewire or embolic protection device. The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protectio[...]

Federal Appellate Court Affirms Summary Judgment For Defendant In Self-Diagnosed Nickel-Allergy Medical Malpractice Case

February 27, 2025

Renee Castaneda suffers from gastroesophageal reflux disease (GERD). To remedy her condition, Castanedasought treatment from Dr. Ronald Richmond, M.D., who recommended implanting a LINX device in Castaneda’s esophagus. A LINX device is a titanium bead-and-wire ring that is surgically implanted aro[...]

Federal Appellate Court Rules IVC Filter Claim Filed Too Late

December 8, 2024

Jessica Gehner was implanted with a Cook Medical inferior vena cava (IVC) filter in Ohio. She later developed abdominal pain, and a March 2013 CT scan revealed that the filter had perforated her IVC. Gehner’s doctors believed that the filter was compressing her small bowel, causing her pain, and r[...]

Class I Recall For Inari Medical’s ClotTriever XL Catheter, 30mm

November 25, 2024

In August 2024, a Class 1 recall (the most serious recall involving a situation where there is a reasonable chance that a product will cause serious health problems or death) was issued for Inari Medical’s ClotTriever XL Catheter, 30mm. The ClotTriever XL Catheter is used for removing clots (t[...]

Federal Appellate Court Affirms Plaintiff Failed To Prove Surgical Scissors Caused Injury

April 21, 2021

The United States Court of Appeals for the Eleventh Circuit (“Federal Appellate Court”) held in its unpublished opinion filed on April 2, 2021: “At best, Pierre’s evidence presents a “mere possibility” that an insulation defect in the Scissors caused her thermal injury. But �[...]

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[...]

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[...]

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[...]

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[...]

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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Tag: medical device claim