267 results

• Medtronic MindFrame Capture LP Revascularization Device Wire May Break, Separate During Use: Recall

  May 21, 2018

  Russell Maas

  A Medtronic MindFrame Capture LP Revascularization Device recall warns that the device has wires that could break off in a patient's body, leading to potential complications and death.

• Medtronic MiniMed Wrongful Death Lawsuit Filed Over Insulin Overdose from Recalled Infusion Sets

  March 27, 2018

  Irvin Jackson

  A wrongful death lawsuit indicates that a woman died due to a malfunctioning Medtronic MiniMed infusion pump which injected her with a week's worth of insulin overnight.

• Medical Device Makers Could Just “Summarize” Malfunction Reports Under Proposed FDA Rule

  March 2, 2018

  Irvin Jackson

  A proposed rule by the FDA could allow medical device manufacturers to simply summarize malfunction reports quarterly, instead of providing full, detailed information.

• Medtronic Heart Implants Recalled Over Failure To Deliver Life-Saving Shocks

  February 27, 2018

  Irvin Jackson

  Medtronic is recalling a number of ICD and CRT-D heart implants due to a defect which could prevent them from providing life-saving shocks to patients.

• Medtronic MiniMed Infusion Set Recall Issued Due to Insulin Overdose Risk

  September 13, 2017

  Irvin Jackson

  Some Medtronic MiniMed infusion sets are being recalled because they can cause an insulin overdose, resulting in life-threatening hypoglycemia.

• Parietex Progrip Mesh Lawsuit Filed Over Hernia Repair Complications

  July 6, 2017

  Irvin Jackson

  A lawsuit over complications linked to the Parietex Progrip indicates that the hernia mesh was defectively designed, causing a Louisiana man to suffer severe internal injuries.

• FDA Issues Warning on Medtronic Surgical Navigation Tools After Patient Deaths

  May 3, 2017

  Irvin Jackson

  The FDA warns that patient injuries and deaths have occurred when doctors used unapproved surgical navigation devices with Medtronic's NavLock Tracker.

• Medtronic HVAD Controller Recall Declared By FDA After Update To Address Safety Issues

  May 1, 2017

  Russell Maas

  A Class I recall has been announced regarding Medtronic HVAD controllers, which are being updated after problems that may have lead to the deaths of at least two patients.

• Medtronic Synchromed II Pump Failure Rates In Older Models May Require Revision Surgery

  April 20, 2017

  Irvin Jackson

  Some older Medtronic SynchroMed II infusion pumps may have a more than 3% chance of battery failure, which could necessitate revision surgery, the company warns.

• Medtronic StrataMR Recall Issued for Adjustable Shunts and Valves

  April 10, 2017

  Martha Garcia

  A recall of about 2,600 Medtronic StrataMR valves and shunts was issued after reports of underdrainage of cerebrospinal fluid which may have caused at least one patient death.