MAHURKAR 8830415003Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521005174), received between Aug 3, 2017 and Jun 19, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING THE CATHETER, THE HEALTHCARE PROFESSIONAL PULLED OUT THE GUIDEWIRE, AND THE DEVICE WAS COMPLETELY TWISTED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A CORRECTIVE AND REMEDIAL ACTION, THE HEALTHCARE PROFESSIONAL CHANGED THE CATHETER. THE PROCEDURE PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289632 ↗
• MalfunctionApr 22, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING PREOPERATIVE PRODUCT TESTING, THE REPORTED PRODUCT WAS RECEIVED AS DEFECTIVE BECAUSE THE SPRING OF THE GUIDE WIRE PROTRUDED OUT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883879 ↗
• MalfunctionDec 27, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A WATER LEAKAGE FROM THE SILICONE TUBE OF THE VENOUS CONNECTOR, AND IT WAS DISCOVERED DURING SALINE FLUSH. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS THE REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE SAME ID AND LOT ON THE SAME DAY OF THE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028366 ↗
• MalfunctionNov 20, 2023Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  ACCORDING TO THE REPORTER, THE PROBLEM WAS ENCOUNTERED IN PLACEMENT OF DIALYSIS CATHETER: GUIDEWIRE INSERTION, DILATATION AND CATHETER INSERTION WITHOUT ANY PARTICULARITY IN THE LEFT JUGULAR VEIN. WHEN REMOVING THE GUIDE WIRE, RESISTANCE SHOULD BE FELT IN THE FIRST FEW CENTIMETERS OF ATTEMPTED REMOVAL. AFTER SEVERAL ATTEMPTS, THE GUIDE WIRE BROKE, FRAYED AND THEN COMPLETELY BROKEN. THEREFORE, ONE PART WAS REMOVED AND THE OTHER PART REMAINED IN PLACE IN THE CATHETER. THE OPERATOR CHANGED, THE CATHETER ASSEMBLY WAS REMOVED AND THE REMAINING PART OF THE GUIDE WIRE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THE CLEANING AGENT ANIOSYME DD1 (SOAKING FOR 15 MINUTES) WAS USED ON THE DEVICE. THE DISTAL END WAS INTACT. THERE WAS NO VISIBLE BREACH IN THE CATHETER BUT THEY DECIDED TO CHANGE EVERYTHING. THE IMMEDIATE ACTION DONE WAS TO CHANGE THE DEVICE. THERE WAS AN ABUNDANT BLEEDING IN THE PATIENT AT RISK FOR THROMBOCYTOPENIA, FLUID OVERLOAD, 15 MINUTES COMPRESSION AND NEW CATHETER RE-INSERTION. THE IMPACTS TO THE PATIENT WERE INCREASED IN CATHETER INSERTION TIME, ADDITIONAL VENIPUNCTURE AT RISK IN THROMBOCYTOPENIA AND A NEED FOR NEW CATHETER INSERTION. THERE WAS NO REPORTED PATIEN

  Patient problems: Insufficient Information

  MAUDE report 18175534 ↗
• MalfunctionAug 8, 2023Break; Product Quality Problem; Obstruction of Flow; Break; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE UNDER LOCAL ANESTHESIA, AT THE TIME OF INSTALLING THE CATHETER, THERE WAS DIFFICULTY IN INSERTING THE GUIDEWIRE AT THE VENOUS SIDE, AND WHEN FLUSHING WAS DONE UPON PASSING PHYSIOLOGICAL SALINE, A SMALL PERFORATION AND LEAK WERE EVIDENCED ON THE MEDIAL SIDE (ASPECT) BELOW THE HUB OF THE DEVICE. THERE WAS NO OCCLUSION. THE GUIDE WIRE USED WAS NOT THE ONE INCLUDED IN THE KIT. THE GUIDE WIRE WAS NOT STUCK. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDE WIRE DID NOT SEPARATE INTO TWO OR MORE PIECES. THE GUIDE WIRE WAS NOT FRAYED, COILED, UNRAVELED, ETC. THERE WAS NO DIMENSIONING ISSUE NOTED. THE DIMENSION(S) OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO CLEANING AGENT WAS USED ON THE DEVICE. THE GUIDEWIRE WAS REMOVED. IT WAS NOT NECESSARY TO REMOVE THE GUIDE WIRE ALONG WITH THE CATHETER. THE CATHETER WAS CHANGED WITH THE SAME PRODUCT ID (ID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484943 ↗
• MalfunctionApr 21, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, UPON REMOVAL DURING OPERATION, THE GUIDEWIRE WAS STUCK IN THE NEEDLE. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, THERE WAS NO LUER ADAPTER ISSUE AND TEGO WAS NOT UTILIZED. IT WAS ALSO STATED THAT IODOPHOR WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE THAT WAS PROVIDED WITH THE KIT WAS THE ONE BEING USED. THE GUIDEWIRE WAS TILL INTACT WHEN IT WAS REMOVED BY HAND. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE GUIDEWIRE AND THE INSERTION NEEDLE WAS REMOVED FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. THE PRODUCT WAS REPLACED WITH THE SAME BATCH AND LOT NUMBER AS THE REMEDIAL ACTION DONE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792417 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING PACKAGING OPENING, DEFORMITY AND ROTATED (SLIGHTLY CURVED) AT THE TIP OF THE CATHETER WAS OBSERVED SO THE PRODUCT WAS NOT USED. THERE WAS NO DAMAGE TO THE OUTER AND INNER PACKAGING. THE PRODUCT WAS STERILE WHEN RECEIVED BY THE CUSTOMER. THE DEVICE RETURNED FOR OBSERVATION AND HANDLING NON-STERILE AS IT HAD BEEN OPENED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENT USED AND THERE WAS NO LUER ADAPTER ISSUE. THEY REPLACED THE PRODUCT WITH ANOTHER CATHETER FROM THE SAME BATCH ON THE SAME DAY. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CANNULA TIP WAS DAMAGED, BENT, OR DISCONNECTED FROM THE CANNULA AS A RESULT OF A MANUFACTURING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464986 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE DOUBLE LUMEN CATHETER PRESENTED ALTERATION WHEN USED IN DIALYSIS (DURING PROCEDURE), PRESENTING ALTER ATION: DISTAL TIP OF THE CATHETER BENT, HOLDING THE GUIDE WIRE, INTERFERING WITH THE OBJECTIVE OF THE MATERIAL. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16462526 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS USED DURING PROCEDURE, DOUBLE LUMEN CATHETER PRESENTED ALTERATION: DISTAL TIP OF THE CATHETER WAS BENT, HOLDING THE GUIDE WIRE, INTERFERING WITH THE OBJECTIVE OF THE MATERIAL. NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16460348 ↗
• MalfunctionJan 26, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE RIGHT INTERNAL JUGULAR CATHETER WAS NOT FUNCTIONAL, A TUNNELING ON A GUIDE WAS SCHEDULED. DURING THE INTRODUCTION OF THE GUIDE IN THE CATHETER, THERE WAS A RESISTANCE SO THE PLACEMENT FAILED. THERE WERE NO CONSEQUENCES FOR THE PATIENT EXCEPT THAT THE PROCEDURE WAS POSTPONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249487 ↗
• MalfunctionNov 15, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS STUCK IN THE CATHETER WHEN IT WAS ALREADY IN THE PATIENT'S VEIN. THERE WAS NO LUER ADAPTER ISSUE AND THE PATIENT HAD HEMATOMA AS THE SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hematoma

  MAUDE report 15798872 ↗
• MalfunctionOct 16, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER KIT WAS PREPARED, THE DOCTOR INSPECTED THE CATHETER AND USED NORMAL SALINE TO IRRIGATE THE CATHETER. THE CHIEF SURGEON INSPECTED THE CATHETER TO BE IN GOOD CONDITION BEFORE THE INSERTION. THERE WAS NO UNUSUAL DESCRIPTION DESCRIBED BY THE SURGEON PRIOR TO THE USE OF THE CATHETER. DURING THE PROCEDURE, A DEFECT (A CLEAN LINEAR CUT) IN THE JUNCTION OF THE CATHETER OR BIFURCATE HUB THAT SEPARATED THE TWO LUMENS WAS DISCOVERED AND THE GUIDE WIRE THAT WAS INCLUDED IN THE KIT DID NOT PASS THROUGH THE CATHETER. PLAIN NORMAL SALINE SOLUTION (PNSS) WAS USED INTRA OPERATIVELY TO VALIDATE THE SURGEON¿S FINDING THAT THERE WAS A SMALL LINEAR CUT IN THE BIFURCATION THUS THEY HAD TO CLEAN THE AREA OF BLOOD FOR BETTER VISUALIZATION. THE CATHETER WAS FLUSHED AFTER ESTABLISHING PATENCY. IT WAS MENTIONED THAT THIS WAS AN ULTRASOUND-GUIDED PROCEDURE. THE GUIDE WIRE WAS STILL INTACT (WHOLE DEVICE WAS INTACT) AND NO X-RAY WAS APPLIED. THE CATHETER WAS NOT REPAIRED AND NORMAL SALINE WAS USED AS A CLEANING AGENT ON THE DEVICE. THERE WAS NO DAMAGE TO THE DEVICE'S PACKAGING AND THE PACKAGING WAS WELL SEALED UPON OPENING FOR USE AT THE OR WORK TABLE. THERE WAS NO EXCESS

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10689919 ↗
• MalfunctionMay 30, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE IMPLANTATION, THE DEVICES HAD A LEAK AT THE VENOUS VALVE (BLUE) AROUND THE CLAMP AREA THAT NECESSITATED THE OPENING OF A NEW CATHETER. THE DEVICE WAS NOT REPAIRED NOR TEGO WAS UTILIZED. NEITHER WAS THIS A LUER ADAPTOR ISSUE. THERE WAS BLEEDING NOTED AND THE PROCEDURE TIME WAS INCREASED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656629 ↗
• MalfunctionApr 19, 2019Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, THERE WAS LACK OF FLOW IN BOTH ARTERIAL AND VENOUS ROUTES UPON CONDUCTING GUIDE WIRE WITHDRAWAL. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED AND FLUSHING WAS DONE SUCCESSFULLY. THERE WAS NO LEAKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532056 ↗
• MalfunctionJul 6, 2018Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING INSERTION OF THE GUIDE WIRE THROUGH THE CATHETER LUMEN, IT COULD NOT PASS THROUGH BOTH VENOUS AND ARTERIAL LUMENS DUE TO SOME BLOCKAGE. IT WAS STATED THAT THE PATIENT WAS ALREADY ON LOCAL ANESTHESIA WHEN THE ISSUE WAS FOUND AND FLUSHING WAS NOT PERFORMED PRIOR TO INSERTION. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS PROVIDED WITH THE KIT BEING USED HOWEVER, THERE WAS RESISTANCE WHEN INSERTING THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667368 ↗
• MalfunctionJul 3, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, WHILE PERFORMING A CATHETER INSERTION PROCEDURE, THE KIT'S GUIDE WIRE COULD NOT PASS THROUGH THE TIP OF THE CATHETER'S LUMEN. IT STATED THAT THERE WAS A BLOCKAGE INSIDE THE LUMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658947 ↗
• MalfunctionApr 20, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER COULD NOT BE TREADED ONTO THE GUIDE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7448949 ↗
• MalfunctionMar 15, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, WHILE PERFORMING INSERTION PROCEDURE, THE DEVICE¿S GUIDE WIRE WAS NOT NEGOTIATING/PASSING THROUGH THE LUMEN OF THE CATHETER. THE DOCTOR CONFIRMED FOR BLOCKAGE OCCLUSION INSIDE THE LUMEN. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341790 ↗
• MalfunctionJan 23, 2018Occlusion Within Device; Difficult to Advance; Occlusion Within Device; Difficult to Advance

  ACCORDING TO THE REPORTER, DURING INSERTION, THE GUIDE WIRE WOULD NOT GO THROUGH THE LUMEN BECAUSE IT WAS PARTIALLY BLOCKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213580 ↗
• MalfunctionAug 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER STATES WHILE INSERTING THE CATHETER THE GUIDE WIRE WOULD NOT PASS THROUGH THE CATHETER BECAUSE IT WAS OCCLUDED. THE CUSTOMER CONTINUED WITH A NEW KIT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6764371 ↗