61 results

• Penumbra Catheter Problems Results in Class Action Lawsuit After Jet 7 Xtra Flex Recall

  January 19, 2021

  Irvin Jackson

  A class action lawsuit accuses of Penumbra of misleading investors by not telling them of problems with its Jet 7 Xtra Flex catheters, which eventually led to a recall and a significant drop in the company's stock market value.

• Cook Medical Flexor Catheter Recall Following Reports of Serious Injuries

  December 29, 2020

  Russell Maas

  A Cook Medical Catheter recall has been given class I status by the FDA following dozens of injuries which occurred when weak bonding sites separated during surgery.

• Penumbra Jet 7 Catheters Carry Risk of Serious Injury and Death, FDA Warns

  December 17, 2020

  Martha Garcia

  The FDA is urgently informing health care personnel of a JET 7 Xtra Flex catheter recall following two hundred incident reports and 14 deaths due to device failures.

• Medtronic Rashkind Balloon Septostomy Catheter Recall Follows Death, Injury Reports

  November 4, 2020

  Russell Maas

  The FDA has upgraded a Medtronic catheter recall to its most serious classification, following reports of two injuries and one death.

• Recalled Catheters Linked To Injuries and Patient Risks Due To Tip Separation Problems, FDA Warns

  May 13, 2020

  Russell Maas

  A recall of nearly 20,000 Applied Medical catheters has been classified as Class I by the FDA following reports of tip separations which could cause serious injury or death for patients.

• Boston Scientific Catheter Recall Issued Over Tip Detachment Risks

  April 8, 2020

  Russell Maas

  The FDA warns that certain Boston Scientific catheter tips could break off inside of patients' blood vessels, putting them at risk of serious injury or death.

• LeMaitre Catheter Recall Issued Due to Risk of Balloon Deflation And Separation

  April 6, 2020

  Russell Maas

  A risk of balloon separation has led to the recall of nearly 50,000 LeMaitre Over the Wire Embolectomy Catheters.

• OriGen Catheter Recall Issued After Reports of Failures Putting Patients At Risk

  September 29, 2017

  Martha Garcia

  Two lots of OriGen ECMO catheters are being recalled following reports of failures that could put patients at risk.

• 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.

• 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.