Medical Device Claims 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[...]

Illinois Appellate Court Affirms Strict Liability For Allegedly Defective Eye Gel Stent Required Expert Testimony

September 28, 2026

Robert F. Babczak filed a complaint alleging strict product liability against AbbVie, Inc. in relation to an intraocular medical device called a XEN gel stent used to treat glaucoma. Babczak alleged that, in January and February 2019, he underwent a series of surgeries intended to halt the progressi[...]

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[...]

Urgent Medical Device Recall For Bolton Medical’s Relay Pro Thoracic Stent Graft System

August 30, 2026

The FDA is aware that Bolton Medical has issued an Urgent Medical Device Recall (Correction) notice providing updated use instructions for all Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above. The notice also recommends customers consider using alternative stent[...]

Federal Appellate Court Affirms Summary Judgment For Defendants In Alleged Defective Surgical Stapler Product Liability Case

August 14, 2026

John Eichin underwent a surgical procedure that required use of several surgical staplers, including one to create an anastomosis that later leaked. In October 2021, he filed this products liability suit against surgical stapler manufacturers. In November 2023, the district court issued its fifth sc[...]

Boston Scientific Issues “Correction” Regarding Massive Recall Of Implantable Pacemakers

July 4, 2026

Boston Scientific’s ACCOLADE family of implantable pacemakers provide dual chamber (atrial and ventricular) bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. In late 2024, Boston Scientific identified a subpopulation of the ACCOLADE family of pacemakers a[...]

Erbe USA Announces Voluntary Recall Of Certain Flexible Cryoprobes

June 23, 2026

“Erbe has initiated a voluntary recall of specific flexible Cryoprobes (being produced from 21.07.2025 and before 14.11.2025) from the market. At the time of this letter [February 12, 2026], Erbe received 43 complaints related to this product problem. The 43 complaints have been id[...]

GAO Report: FDA Falling Short Regarding Medical Device Recalls

February 8, 2026

The United States Government Accountability Office (GAO) issued a report to the United States Congress in December 2025 entitled “HHS and FDA Should Address Limitations in Oversight of Recall Process” in which it stated: From fiscal years 2020 to 2024, FDA oversaw the recall of 3,934 med[...]

$37.76 Million Settlement With CVS For Over-Dispensing Insulin Pens To Patients

January 20, 2026

The United States Attorney for the Southern District of New York announced on December 2, 2025 that the United States has filed and settled a healthcare fraud lawsuit against national retail pharmacy chain CVS PHARMACY, INC. (“CVS”). The settlement resolves allegations that, from 2010 throu[...]

OIG Report: Medicare Improperly Paid Suppliers $22.7 Million Over 7 Years for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Provided to Enrollees During Inpatient Stays

December 14, 2025

Durable Medical Equipment Durable medical equipment (DME) is generally defined as equipment that can withstand repeated use, serves primarily a medical purpose, is not generally useful to a person in the absence of an illness or injury, and is appropriate for use in an enrollee’s home. Examples of[...]

Georgia Supreme Court Discusses How Statute Of Repose Applies In Chemical Hair Relaxer Cancer Case Where Many Units Bought Over Many Years

December 9, 2025

Georgia law imposes strict liability on manufacturers of products that cause injury because of their condition when sold. OCGA § 51-1-11(b)(1). Georgia law also puts an outer limit on when an action for strict products liability may be brought: no such action may be commenced “with respect to an [...]

Certain FreeStyle Libre® 3 And FreeStyle Libre 3 Plus Sensors In The U.S. May Have Been Defective

November 25, 2025

On November 24, 2025, Abbott announced that it has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings. If undetected, incorrect low [...]

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Category: Medical Device Claims