97 results

• Abbott Coronary Catheter Recall Issued Over Balloon Sheath Problems

  May 17, 2017

  Russell Maas

  Hundreds of thousands of Abbott coronary catheters have been recalled over problems with a protective balloon sheath that have been linked to at least one patient death.

• Medical Device Connectors To Be Standardized To Avoid Misconnection Injuries: FDA

  May 5, 2017

  Martha Garcia

  The FDA has called on manufacturers to roll out new, standardized medical device connectors to avoid potential medical mistakes caused by misconnections.

• Wingman35 Catheter Recall Issued Over Tip Splitting, Separation Problems

  May 4, 2017

  Russell Maas

  More than 2,300 Wingman35 catheters are being recalled due to the risk of splitting and tip separation, which can cause a loss of blood flow to organs, resulting in serious injury or death.

• Central Line Catheter Infections Greatly Reduced By Targeted Prevention Steps: Study

  January 27, 2017

  Martha Garcia

  A new study finds that a number of safety measures used in some hospitals can dramatically reduce the number of central line catheter infections.

• Cook Medical Catheter Wire Guide Recall Issued Over Raw Materials Problem

  August 16, 2016

  Irvin Jackson

  A Cook Medical Catheter Wire Guide recall has been issued due to the risk of glass particles in the coating.

• Stryker Catheter Recall Issued Due To Tip Separation

  July 25, 2016

  Irvin Jackson

  A catheter recall for some Stryker catheters has been rated a Class I medical recall by the FDA, which warns that reports of tip separations means that the devices could cause serious injury or death.

• Cook Beacon Tip Catheter Recall: Fracturing Could Cause Embolism, Other Injuries

  May 5, 2016

  Russell Maas

  A recall of more than 4 million Cook Medical Beacon Tip catheters has been announced following reports that the tips can fracture, requiring emergency removal procedures.

• Fetch 2 Aspiration Catheter Recall Issued Due to Risk of Shaft Breakage

  April 12, 2016

  Russell Maas

  A recall has been announced for the Fetch 2 Aspiration Catheter following reports that it broke during medical procedures.

• Arrow Intra-Aortic Balloon Catheter Kit Recall Issued After Patient Death, Bleeding Injuries

  March 14, 2016

  Martha Garcia

  Thousands of Arrow catheter kits are being recalled worldwide after one patient died and several were injured from bleeding problems that occurred when the sheath body and hub became separated.

• Coating on Intravascular Devices May Peel Off, Causing Injury and Death, FDA Warns

  November 24, 2015

  Russell Maas

  The FDA warns that the coatings on some intravascular devices, such as catheters and guidewires, may flake off, resulting in severe injuries and death among patients.