291 results

• Venture Catheter Recall Issued Over Reports of Tip Splitting, Separations

  June 22, 2017

  Russell Maas

  Problems with tip separations and potential injuries and deaths to patients have resulted in a recall of more than 7,000 Venture catheters.

• Zimmer Biomet Spinal Fusion Stimulator Recall: Harmful Chemicals

  June 1, 2017

  Irvin Jackson

  Zimmer Biomet spinal fusion stimulators are being recalled due to a high level of chemicals which may be toxic and could cause serious injury or death.

• Heartmate II LVAS Pocket Control Recall Issued Following Deaths, Malfunctions

  May 25, 2017

  Irvin Jackson

  About 29,000 HeartMate II LVAS pocket controllers are subject of an FDA recall warning following the death of 26 patients who tried changing the controller improperly or too slowly.

• 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 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.

• Phillips HeartStart Rx Defibrillator Recall Issued Over Electrical Problems

  March 27, 2017

  Martha Garcia

  The FDA has issued a Class I recall notice for the HeartStart Rx Defibrillator, warning that electrical problems could cause the device to fail to deliver life-saving shocks.

• EpiPen Recall Issued Outside U.S., Due to Risk Emergency Allergy Drug May Not Work

  March 24, 2017

  Russell Maas

  A recall of more than 80,000 EpiPens in Europe and Asia was announced following reports that the devices failed to deliver medication when used.

• LIFEPAK 1000 Defibrillators May Shut Down During Use, FDA Warns

  March 9, 2017

  Russell Maas

  Problems with the LIFEPAK 1000 defibrillator could cause a failure to deliver life-saving shocks, resulting in an FDA Class I recall classification.

• 3M Claims False Bair Hugger Recall Rumors Being Spread By Competitor

  February 27, 2017

  Irvin Jackson

  3M claims a competitor is spreading false Bair Hugger recall claims in order to drum up more litigation against the company, which already faces hundreds of hip infection and knee infection lawsuits linked to the forced air warming blanket.

• Zimmer Biomet Shoulder Recall Issued Amid High Fracture Rate

  February 16, 2017

  Irvin Jackson

  A recall of more than 3,000 Biomet shoulder implants has been linked to a high rate of fractures that could cause the need for revision surgery.