medical device recall 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[...]

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[...]

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[...]

Medtronic Recalls All Unused Valiant Navion™ Thoracic Stent Graft System

April 1, 2021

On February 23, 2021, Medtronic plc (Medtronic) announced its voluntary recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. Medtronic initiated the recall in response to information recent[...]

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[...]

Class I Recall Of More Than 322,000 Medtronic MiniMed Insulin Pumps For Incorrect Insulin Dosing

March 6, 2020

The FDA announced on February 12, 2020 a Class I recall of 322,005 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) (all lots before October 2019) and Model 670G (MMT-1780) (all lots before August 2019). The distribution dates for Model 630G were from September 2016 to October 2019, and the di[...]

Medtronic Issues Recall Of Its 6 French Sherpa NX Active Guide Catheters Due To Separation And Fragmentation Issue

December 12, 2019

Medtronic announced on October 8, 2019 that it was recalling its 6 French Sherpa NX Active Guide Catheters due to a separation and fragmentation issue. The 6 French Sherpa NX Active Guide Catheter is used to access veins and arteries inside and outside of the heart (coronary and peripheral vascular [...]

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[...]

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[...]

Report Finds Pharmaceutical Recalls And Medical Device Recalls Were Up In First Quarter 2018

July 10, 2018

The First Quarter 2018 “Recall Index” published by Stericycle Expert Solutions (“Stericylce,” which “provides global and local expertise before, during, and after a recall threat” and each quarter of the year analyzes cumulative recall data across five product cat[...]

AVAIRA Toric Soft Contact Lenses Recalled

October 18, 2011

The FDA has announced a Class 1 recall for AVAIRA Toric (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the recalled product[...]

Medical Device Recalls Need Better Oversight

July 20, 2011

The evaluation and approval of medical devices used in the United States come under the oversight of the U.S. Food and Drug Administration (FDA). The FDA does not only oversee the approval of medical devices but also oversees the recalls of medical devices, which often are voluntarily initiated by[...]

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