PROTEK Duo 5140-4629Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814112020166), received between Nov 2, 2018 and Jun 10, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  LIVANOVA RECEIVED A REPORT THAT THE CUSTOMER EXPERIENCED DIFFICULTY INSERTING A PROTEKDUO 29FR CANNULA VIA THE RIGHT INTERNAL JUGULAR VEIN. THIS OCCURRED AFTER THE CUSTOMER ALREADY HAD EXPERIENCED DIFFICULT INSERTION OF A 31FR PROTEKDUO. THE 29FR CANNULAE WAS REMOVED AND THE PHYSICIAN NOTED THAT TISSUE WAS EXTRACTED WITH THE CANNULA UPON REMOVAL.

  Patient problems: Perforation of Vessels

  MAUDE report 19498406 ↗
• MalfunctionDec 1, 2023Leak/Splash; Leak/Splash

  LIVANOVA RECEIVED A REPORT THAT A PATIENT WAS IMPLANTED WITH 29FR PROTEKDUO VIA AN LVAD INSERTION AND THE USER REPORTED DIFFICULT PLACEMENT AND DIFFICULT TO ACHIEVE THE DESIRED FLOWS. UPON INITIATING FLOWS, THE USER REPORTED SEEING AIR BUBBLES UNDER ECHO IN THE RIGHT SIDE OF THE HEART. THERE WAS SUSPICION OF A CRACK IN THE CANNULA CAUSING AIR ENTRAINMENT OR CAVITATION FROM FEMORAL AND RA DRAINAGE. A FEMORAL CANNULA ALONG WITH THE PROTEKDUO WERE USED AS DRAINAGE WHILE RETURN CANNULATION WAS PLACED SURGICALLY IN THE CHEST. THE PATIENT CONTINUED TO IMPROVE AND WAS SUPPORTED UNTIL (B)(6) 2023 WHEN THE DECISION WAS MADE TO REMOVE THE PROTEKDUO AND CONTINUE LVAD AND RVAD SUPPORT PERIPHERALLY. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247459 ↗
• MalfunctionOct 9, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  LIVANOVA RECEIVED A REPORT THAT DURING INSERTION OF A PROTEKDUO 29FR CANNULA, A KINK DEVELOPED WHEN THE USER ATTEMPTED TO ADVANCE THE CANNULA AND THEY WERE UNABLE TO FULLY ADVANCE IT. THE USER ATTEMPTED MULTIPLE TIMES TO REPOSITION THE CANNULA BUT WERE UNSUCCESSFUL. ANOTHER CANNULA WAS OPENED TO PROCEED WITH THE CASE AND THERE WERE NO ISSUES WITH THE SECOND DEVICE. THERE WAS NO PATIENT HARM REPORTED. ON SEPTEMBER 15, 2023, LIVANOVA RECEIVED A USER MEDWATCH REPORT, MW5145280, WHICH PROVIDED ADDITIONAL INFORMATION ABOUT THE EVENT. THE REPORT INDICATED THAT THE PATIENT WAS BEING CANNULATED FOR ECMO UNDER CONTINUOUS FLUOROSCOPY IN AN ICU SETTING. VASCULAR ACCESS WAS REPORTEDLY OBTAINED, THE GUIDEWIRE WAS PLACED AND THE VESSEL WAS DILATED WITHOUT DIFFICULTY. UPON INSERTION, THE USER NOTED DIFFICULTY AND RESISTANCE AND UPON INSPECTION AFTER REMOVAL IT WAS FOUND TO HAVE TWO BENDS IN THE WIRE REINFORCED PORTION OF THE CANNULA. THIS EVENT IS BEING REPORTED IN RESPONSE TO RECEIPT OF THIS USER MEDWATCH REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901404 ↗
• InjuryAug 8, 2023Obstruction of Flow; Obstruction of Flow

  DURING A LITERATURE REVIEW, LIVANOVA IDENTIFIED AN ARTICLE (GORTON ET AL., 2023) WHICH DESCRIBED A 55-YEAR-OLD MALE PATIENT WHO WAS EVALUATED FOR LUNG TRANSPLANTATION FOR COVID-19 ARDS AND ADVANCED FIBROTIC CHANGES. THE PATIENT WAS SUBSEQUENTLY TRANSITIONED TO OXYRVAD SUPPORT WITH A 29F PROTEKDUO VIA THE RIGHT INTERNAL JUGULAR VEIN. APPROXIMATELY TWO WEEKS AFTER THIS CONVERSION, THE PATIENT REPORTED ACUTE ONSET BLURRED VISION. A CT SCAN OF THE HEAD WAS PERFORMED, WHICH IDENTIFIED BILATERAL SUPERIOR OPHTHALMIC VEIN ENLARGEMENT CONCERNING FOR CEREBRAL VENOUS CONGESTION (SUPERIOR VENA CAVA SYNDROME). FOLLOWING RECONFIGURATION TO 2-STICK OXY RVAD VIA LEFT INTERNAL JUGULAR VEIN AND RIGHT FEMORAL VEIN DRAINAGE, THE NEUROLOGIC SYMPTOMS RESOLVED.

  Patient problems: Blurred Vision; Low Blood Pressure/ Hypotension

  MAUDE report 17481407 ↗
• DeathNov 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER INSERTING THE PROTEK DUO VENO-VENOUS CANNULA AND POSITIONING THE TIP THROUGH THE PULMONIC VALVE INTO THE PULMONARY ARTERY, THE DEVICE SLIPPED BACK AND THE PHYSICIAN DECIDED TO RE-POSITION. THE CANNULA WAS PUSHED FORWARD AND PERFORATED THE PULMONARY ARTERY. A SURGEON WAS CALLED AND WAS IN THE ROOM WITHIN 3 MINUTES AND WAS UNABLE TO CONTAIN THE PERFORATION. THE PATIENT EXPIRED.

  Patient problems: Death; Perforation

  MAUDE report 8033968 ↗