MAHURKAR 8813817005Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521004894), received between Jul 24, 2017 and Jul 18, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IMMEDIATELY AFTER IMPLANTATION AND DURING DIALYSIS ON THE SAME DAY OF IMPLANTATION, THE ARTERIAL SILICONE EXTENSION TUBE HAD LEAKED BLOOD. THE CLAMPS WERE MOVED PERIODICALLY. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO ABNORMALITIES OBSERVED PRIOR TO USE. FLUSHING WAS NOT PERFORMED PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. NO OINTMENT USED. THE PRODUCT WAS REPLACED ON THE SAME DAY WITH THE SAME PRODUCT ID (IDENTIFIER), SAME MANUFACTURER AND SAME LOT AND THE PROCEDURE WAS COMPLETED. THERE WAS APPROXIMATELY 10ML OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347576 ↗
• MalfunctionJun 1, 2023Product Quality Problem; Unraveled Material; Defective Component; Product Quality Problem; Unraveled Material; Defective Component

  ACCORDING TO THE REPORTER, WHILE ATTEMPTED FOR PROCEDURE, THE KIT'S GUIDEWIRE WAS FRAYED INSIDE THE PACKAGING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE ASIDE FROM THE REPORTED ISSUE. THERE WAS NO DAMAGE TO THE DEVICE'S EXTERNAL PACKAGING AND BOX. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, THERE WAS NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. A CREDIT NOTE WAS ISSUED AS THE REMEDIAL ACTION DONE TO ADDRESS THE ISSUE AND THE PRODUCT WAS NOT REPLACED. 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. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043763 ↗
• MalfunctionSep 9, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE ARTERIAL SIDE OF CATHETER'S EXTENSION TUBE CANNOT BE INSERTED INTO THE GUIDE WIRE. IT WAS ALSO NOTED THAT THERE WAS A HOLE IN THE CATHETER SHAFT NEAR THE TIP. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15397282 ↗
• MalfunctionSep 8, 2022Break; Product Quality Problem; Obstruction of Flow; Break; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE CATHETER ON THE ARTERY SIDE (RED SIDE) CANNOT BE INSERTED INTO THE GUIDE WIRE. THERE WAS A HOLE AT BOTTOM PART OF THE CATHETER SHAFT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THE CLEANING AGENT USED ON THE DEVICEWAS NORMAL SALINE, AND TEGO WAS NOT UTILIZED. THE CATHETER WAS REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382488 ↗
• MalfunctionMar 8, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PATIENT WAS ADMITTED IN ICU (INTENSIVE CARE UNIT) WITH CKD (CHRONIC KIDNEY DISEASE) AND HAD FEMORAL STRAIGHT EXTENSION CATHETER INSERTED. IMMEDIATELY PATIENT HAS UNDERGONE DIALYSIS AND THEY FOUND THE LEAKAGE AT THE VENOUS (BLUE) SILICONE EXTENSION (JUNCTION OF EXTENSION TUBE AND BIFURCATE). THE DIALYSIS WAS STOPPED, CATHETER WAS EXPLANTED AND A FRESH CATHETER WAS INSERTED. IT WAS STATED THAT CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA AND CLAMPS ARE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. NO OTHER DEFECTS /DAMAGES WAS FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE AND FLUSHING WAS DONE AND NOTHING WAS FOUND. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS BUT NO TRANSFUSION WAS REQUIRED. THE CATHETER WAS NOT REPAIRED, ALCOHOL BASED CHLORHEXADINE SOLUTION WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435096 ↗
• MalfunctionOct 3, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDE WIRE GOT STUCK WHILE INSERTING INTO THE PATIENT. GW (GUIDE WIRE) DID NOT COME OUT OF THE VENOUS END ULTEM ADAPTER AND GOT STUCK INSIDE THE CATHETER. THE PHYSICIAN HAD TO USE A NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152305 ↗
• MalfunctionOct 3, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, GUIDE WIRE WAS STUCK DURING THE PROCEDURE WHILE INSERTING THE CATHETER INTO THE PATIENT. IT WAS STATED THAT THE GUIDE WIRE DID NOT COME OUT OF THE VENOUS END OF THE ULTEM ADAPTER AND WAS STUCK INSIDE THE CATHETER. THEY HAD TO USE A FRESH CATHETER TO COMPLETE THE PROCEDURE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, BETADINE WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150867 ↗
• MalfunctionMar 19, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS SESSION, THE DEVICE HAD BLOOD LEAKAGE (2-3 ML) AT THE LUER ADAPTER (RED) AND A CRACK WAS ALSO OBSERVED AT THE ARTERIAL ADAPTER. IN ORDER TO COMPLETE THE DIALYSIS TREATMENT, CATHETER WAS REMOVED AND REPLACED. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, AND THERE WAS NO OTHER INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434423 ↗
• MalfunctionSep 13, 2018Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS LEAKAGE FROM THE JUNCTION OF EXTENSION TUBES AND BIFURCATE. IT WAS REPORTED CATHETER WAS REMOVED AND IT WAS REPLACED WITH NEW PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872864 ↗
• MalfunctionAug 22, 2018Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CATHETER¿S LINE WAS BLOCKED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7806124 ↗
• MalfunctionJun 28, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE GUIDE WIRE WAS NOT PASSING THROUGH THE CATHETER. IT WAS STATED THAT FLUSHING WAS PERFORMED PRIOR TO USE AND IT WAS SUCCESSFUL. ANOTHER CATHETER WAS USED AND THERE WAS NO ISSUE WITH THE GUIDE WIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7645347 ↗
• InjuryDec 14, 2017Break; Break

  ACCORDING TO THE REPORTER, AFTER INSERTING THE CATHETER, WHILE REMOVING THE GUIDE WIRE, IT GOT STUCK AND BROKE. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LAB AND THE BROKEN GUIDE WIRE WAS REMOVED BY THE INTERVENTIONAL CARDIOLOGIST. THE CATHETER WAS DISCARDED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7117036 ↗
• MalfunctionOct 19, 2017Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, LEAKAGE WAS OBSERVED ON THE VENOUS LUMEN AT THE HUB AND LUER ADAPTER WHILE CHECKING THE PRODUCT BEFORE IN SERTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6960899 ↗
• MalfunctionJul 24, 2017Occlusion Within Device; Difficult to Remove; Occlusion Within Device; Difficult to Remove

  THE CUSTOMER STATES WHILE DOING A PRE OPERATIVE CHECK, THE GUIDE WIRE GOT STUCK IN THE CATHETER AT THE HUB DUE TO A BLOCKAGE. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6735275 ↗