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• Medtronic Sprint Fidelis® Defibrillator Leads
  The Sprint Fidelis® Defibrillator Lead is subject to a Class 1 recall by the FDA.  Class 1 recalls are the most serious type of recalls and involve situations in which there is a reasonable probability that use of product will cause serious injury or death. The Recall Medtronic, Inc. (Medtronic), ...

• Guidant/Medtronic Defibrillators
  Tens of thousands of Americans rely on implantable pacemakers and defibrillators—cardiac devices that deliver electrical currents and/or shocks to the heart to keep it beating at a normal rhythm.  In recent years, two different brands of implantable pacemakers and defibrillators—Guidant and Med...

• As Heartware Recalls Continue, Patients Cope with the Time Bomb in Their Chests
  “It sounded like a cement mixer.” This is how one Medtronic HeartWare HVAD patient described the sound coming from deep within his chest after the device became clogged with a blood clot. Years after the initial recall was ordered under a Class I status by the FDA, thousands of patients across t...

• The HeartWare HVAD System is Under a Class I Recall…Again
  The FDA recently announced that the HeartWare HVAD system was being recalled by medical device manufacturer MedTronic over concerns of battery failure. The recall marks the second time the device has been recalled, with both occurrences falling under Class I status. The Class I recall is the FDA’s...

• FDA Faces Congressional Investigation Over Lack of Reaction to Heart Device Recall
  The FDA’s ongoing failures to protect and represent the American people have finally caught the eyes of congressional legislators and the agency now finds itself on the hot seat over the way it handled – or failed to handle – the Medtronic HeartWare Ventricular Assist Device recall. 14 patient...

• FDA Warns on Leadless Heart Pacing Systems
  After observing what it calls “major complications related to cardiac perforation” in patients undergoing pre-market trials for Medtronic’s Micra leadless pacemaker, the FDA has reiterated its warnings to cardiac care providers over the use of leadless devices. Pacemakers generally come in one...

• Another Day, Another Story of the FDA Failing the American People
  In a narrative that has become all too familiar when referring to one of the most openly corrupt institutions in the American government, reports have surfaced that the FDA knowingly allowed a faulty medical device to make its way into unwitting patients. This time the device in question is quite li...

• IVC Filter Cases Consolidated in MDL; Lopez McHugh Taking Referrals
  A year-long investigation by NBC Nightly News has raised serious questions about why medical device manufacturer C.R. Bard, Inc. continued to sell and market its inferior vena cava (IVC) filters even after it seems to have become aware that its filters were failing and causing death and other seriou...

• Children’s Tracheostomy Tubes Recalled After Serious Injuries
  The FDA recently announced that approximately 70,000 children’s tracheostomy tubes have been recalled by Medtronic after it received hundreds of reports of issues with a recent redesign. The FDA stated that there have at dozen reports of serious injury from the new tubes, which have an angle that ...

• CDC: Decontamination Procedures Not Followed After Creutzfeldt-Jakob Patient Treated
  CNN reports that several patients who underwent surgery at a Massachusetts Hospital may have been exposed to rare and dangerous disease due to improper sterilization of medical equipment from another facility in New Hampshire. The medical equipment, rented by Medtronic Inc., was initially used on a ...