Kodama Catheter Recall Issued Due To Risk Broken Pieces May Flush Into Patient Arteries
The FDA has determined a problem with Kodama ultrasound catheters could put patients at risk of death, resulting in a nationwide recall.
Search Results For: catheter recalls
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Penumbra Catheter Recall Over JET 7 Xtra Flex Tip Damage Categorized as Class I by FDA
The FDA has issued a Class I classification to a Penumbra Jet 7 Xtra Flex Catheter recall, following reports of deaths and severe patient injuries.
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Boston Scientific Recalls and Discontinues Lotus Edge Aortic Valve System For TAVR Surgeries
Boston Scientific is recalling and removing its Lotus Edge TAVR system from the market due to problems with the complexity of the delivery system.
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Cook Medical Flexor Catheter Recall Following Reports of Serious Injuries
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.
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Medtronic Rashkind Balloon Septostomy Catheter Recall Follows Death, Injury Reports
The FDA has upgraded a Medtronic catheter recall to its most serious classification, following reports of two injuries and one death.
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Recalled Catheters Linked To Injuries and Patient Risks Due To Tip Separation Problems, FDA Warns
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…
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Boston Scientific Catheter Recall Issued Over Tip Detachment Risks
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.
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LeMaitre Catheter Recall Issued Due to Risk of Balloon Deflation And Separation
A risk of balloon separation has led to the recall of nearly 50,000 LeMaitre Over the Wire Embolectomy Catheters.
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Sapien 3 Transcatheter Heart Valve Recall Follows Reports Of Balloons Bursting During Implantation
A recall warns that Sapien 3 Transcatheter Heart Valve balloons may explode while being implanted, which has already resulted in 17 injuries and one patient death.
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OriGen Catheter Recall Issued After Reports of Failures Putting Patients At Risk
Two lots of OriGen ECMO catheters are being recalled following reports of failures that could put patients at risk.