111 results

• Medtronic TurboHawk Catheter Recall Issued Due to Tips Breaking

  March 10, 2022

  Randy Dixon, Jr.

  The FDA has given a class I designation to a recall of Medtronic TurboHawk atherectomy systems due to a risk of the catheter tips breaking off and causing life-threatening arterial injuries.

• Medtronic HawkOne Directional Atherectomy System Recall Issued Over Broken Tip Risks

  January 25, 2022

  Irvin Jackson

  Medtronic is recalling more than 95,000 HawkOne Directional Atherectomy Systems whose catheter tips could break off, putting patients' lives at risk.

• Do Not Use ChloraPrep 3 mL Applicators Due to Microbial Contamination Risk, FDA Warns

  March 22, 2021

  Russell Maas

  The FDA is warning against the use of certain BD ChloraPrep applicators due to the risk of microbial contamination and infections.

• 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.

• 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.

• Catheter-Associated Urinary Tract Infection Problems May Occur Even With Preventative Measures: Study

  April 23, 2020

  Russell Maas

  A new study challenges the belief that all catheter-associated urinary tract infections could be avoidable.

• 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.

• Nursing Homes With High Numbers Of Patients With Serious Mental Illness Have Worse Outcomes: Study

  July 31, 2019

  Martha Garcia

  A new study finds that residents in nursing homes with high numbers of patients with serious mental illness face a higher chance of adverse health events, even if they are not mentally ill themselves.

• 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.