Medtronic Faces Surgical Stapler Lawsuits In Minnesota, Texas
Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.
You may also be interested in...
FDA Ends Summary Reporting Program, Releases 20 Years Of Adverse Events, Vows To Make MAUDE 'User-Friendly'
The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.
A US FDA panel unanimously agreed that surgical staplers should be reclassified into class II on 30 May, backing FDA recommendations.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.