medical device recall lawyers 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[...]

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[...]

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[...]

Class I Recall Of Abdominal Stent Graft

September 5, 2020

The FDA has announced a Class I recall, the most serious type of recall, of all lots of Endologix Ovation iX Abdominal Stent Graft System manufactured from 2015 to the present, which involves 5,403 such medical devices. The Ovation iX Abdominal Stent Graft System is intended to treat patients with a[...]

Tag: medical device recall lawyers

Abiomed Recalls Automated Impella Controllers For Updated Use Instructions

GAO Report: FDA Falling Short Regarding Medical Device Recalls

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

Class I Recall Of Abdominal Stent Graft

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