MAHURKAR 8888145002Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521014145), received between Jun 28, 2018 and Nov 7, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111372); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1320-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THERE WAS A BREAKAGE OF THE TUNNEL PIN. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500659 ↗
• MalfunctionApr 25, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT AT 10:50 A.M., HEMODIALYSIS RENAL REPLACEMENT THERAPY WAS PLANNED, AND PERCUTANEOUS SELECTIVE VENOUS CATHETERIZATION WAS PERFORMED. DURING THE PROCESS OF ESTABLISHING A SUBCUTANEOUS TUNNEL USING THE CENTRAL VENOUS CATHETER, THE TUNNEL NEEDLE (PIN) DETACHED FROM THE OUTER RUBBER SLEEVE AND WAS IMMEDIATELY REMOVED FROM THE SUBCUTANEOUS LAYER. THE DETACHED RUBBER SLEEVE WAS REMOVED WITH HEMOSTATIC FORCEPS, AND THE TUNNELS NEEDED TO BE RE-ESTABLISHED OR THE KIT WAS REPLACED WITH ANOTHER ONE FROM THE SAME LOT AND ID. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETERIZATION CONTINUED WITHOUT CAUSING DIRECT HARM TO THE PATIENT, HOWEVER, DUE TO THE EVENT, IT INCREASED THE OPERATION TIME AND TRAUMA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910631 ↗
• MalfunctionMar 21, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, WHEN THE PATIENT UNDERWENT LONG-TERM CENTRAL VENOUS CATHETER IMPLANTATION FOR, HE MODIALYSIS, THE CATHETER WITHDRAWAL DIFFERENCE COULD NOT BE DIALYZED NORMALLY. THE CATHETER HAD DIFFERENTIAL FLOW DUE TO CATHETER POSITION PROBLEMS. ON (B)(6), THE CATHETER POSITION WAS CHECKED UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY), AND THE VENOUS END WAS WITHDRAWN AT THAT TIME, AND THE ARTERIAL SEGMENT WAS STILL WITHDRAWN. AFTER THE POSITION WAS ADJUSTED, THE WITHDRAWAL DIFFERENCE WAS STILL MADE, AFFECTING THE PATIENT'S NORMAL DIALYSIS EFFECT. THEREFORE, THE POSITION WAS ADJUSTED TO COMPLETE THE TREATMENT FOR THE PATIENT UNDER DSA. THE ADVERSE EVENT WAS REPORTED TO THE EQUIPMENT DEPARTMENT AS SOON AS POSSIBLE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662520 ↗
• MalfunctionMar 12, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, DURING DIALYSIS, THE ARTERIAL END CONNECTOR WAS FOUND TO BE CRACKED. ON (B)(6) 2025, THE ARTERIAL END CONNECTOR WAS REPLACED AT THE HEMODIALYSIS CLINIC. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21583137 ↗
• MalfunctionMar 12, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PATIENT WAS PLACED WITH A CENTRAL VENOUS CATHETER FOR HEMODIALYSIS AT THE CLINIC. ON THE DAY OF THE EVENT, THE VENOUS END CONNECTOR WAS FOUND TO BE CRACKED DURING DIALYSIS; THE SAME DAY, THE VENOUS CATHETER END CONNECTOR WAS REPLACED AT THE HEMODIALYSIS CLINIC. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583109 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER¿CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY STUCK TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE CUSTOMER NOTICED THAT THERE WAS INSUFFICIENT FLOW DURING THE FIRST USE OF THE CATHETER AFTER CATHETERIZATION. THE CURRENT USAGE SHOWED THAT REVERSING WAS NOT POSSIBLE, BUT THE FORWARD FLOW WAS NOT GOOD. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION HAVE BEEN REFLECTED IN THE COURSE OF THE DISEASE AND DIALYSIS RECORDS. THE DR CHEST RADIOGRAPH CATHETER WAS AT THE INNER PORT AT THE TH9 LEVEL. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. THE INCIDENCE OF CATHETER FLOW DIFFERENCE WAS AS HIGH AS 71.43%. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DAMAGE WAS FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED WITH NORMAL RESULTS. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. NO CLEANING AGENT WAS USED ON THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER; THERE WAS

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139428 ↗
• MalfunctionSep 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, 5 DAYS AFTER CATHETER WAS INSERTED, DURING DIALYSIS SESSION, NO BLOOD FLOW WAS OBSERVED FROM THE BLUE (VENOUS) PORT. THE CUSTOMER TRIED TO REVERSE THE LINES, BUT REVERSE FLOW WAS NOT SUCCESSFUL AND IT WAS NOT MUCH OF A GOOD FLOW. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND SAME LOT ON THE NEXT DAY OF THE EVENT. THE NEW DEVICE WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE AND IT WAS OKAY. THE LINE WAS NOT HARD TO FLUSH WITH THE SYRINGE, THERE WAS BLOOD RETURN PRIOR TO SYRINGE FLUSH, HEPARIN WAS THE ANTI-COAGULATION USED, AND THIS WAS NOT THE INFUSION LINE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION, THE DIMENSION(S) OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL, THERE WAS NO OCCLUSION, NO OTHER DEFECTS/D AMAGES FOUND ON THE PRODUCT, AND THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533124 ↗
• MalfunctionJan 28, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS, LEAKAGE WAS OBSERVED FROM THE JUNCTION OF THE ARTERIAL EXTENSION TUBE AND BIFURCATE. IT WAS ALSO MENTIONED THAT THERE WAS A GREATER THAN 2 ML OF BLOOD LOSS. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER WITH THE SAME MODEL AS THE INTERVENTION/TREATMENT REQUIRED FOR THE LEAKAGE AND THE TREATMENT WAS COMPLETED. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS ALSO STATED THAT BLOOD TRANSFUSION WAS NOT REQUIRED, FLUSHING WAS PERFORMED WITH SUCCESSFUL RESULT, THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, THERE WAS NOT OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED, BETADINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT AND CHLORHEXIDINE WAS USED AS THE CLEANING AGENT TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242972 ↗
• InjuryAug 28, 2020Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, IT WAS REPORTED THAT THERE WAS NO DAMAGE ON THE DEVICE ON VISUAL INSPECTION AND NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE BUT INTRA-OPERATIVELY, IT WAS STATED THAT THEY HAD A PROBLEM INSERTING THE WIDEST SHEATH DURING CATHETER INSERTION. THE PULL APART SHEATH HAD A WAVY, SHARP EDGE, AND ROLLED UP IN THE VESSEL. AS A RESULT, SLIGHT VESSEL DAMAGE WAS OBSERVED CAUSED BY THE ROLLING OF THE SHEATH AND THERE WAS SIGNIFICANT TISSUE DAMAGE. IT WAS STATED THAT THE CATHETER FROM THE SET WAS STILL IMPLANTED AS IT WAS NOT DAMAGED, BUT THEY HAD TO USE ADDITIONAL SET OF DILATOR WITH VALVE FROM A COMPETITOR TO COMPLETE THE PROCEDURE IN THE OR (OPERATING ROOM). AFTER THE PROBLEMATIC INSERTION SURGICAL INTERVENTION WAS NECESSARY TO CLOSE DAMAGED SMALL VESSEL AND SURROUNDING TISSUE. IT WAS ALSO REPORTED THAT THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS AND TRANSFUSION WAS REQUIRED.

  Patient problems: Perforation of Vessels; Tissue Damage

  MAUDE report 10469161 ↗
• MalfunctionFeb 17, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, A LEAKAGE WAS OBSERVED ON THE RED (ARTERIAL) LUER ADAPTER. IT WAS STATED THAT A CRACK WAS OBSERVED ON THE ADAPTER WHICH CAUSED THE LEAK. IT WAS ALSO STATED THAT NO INSTRUMENT WAS USED TO TIGHTEN AND LOOSEN THE DEVICE. THERE WAS BLOOD LOSS OF 3 ML AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NOTHING UNUSUAL OBSERVED IN THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WAS UTILIZED WITH THE DEVICE. BETADINE WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED. IT WAS STATED THAT THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE AND THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE OF THE DEVICE. THE CATHETER WAS NOT REPAIRED AND THE FAULTY CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER OF THE SAME MODEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716923 ↗
• MalfunctionJan 24, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING USE, LEAKAGE WAS OBSERVED AT THE JOINT OF EXTENSION TUBE AND BIFURCATE DURING ROUTINE DIALYSIS. IT WAS STATED THAT THERE WERE NO PRIOR ISSUES AFTER INSERTION AND GOOD FLOW WAS OBSERVED. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT USED AND THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED PRIOR TO INSERTION. CATHETER WAS REPLACED WITH A NEW ONE. IT WAS ALSO STATED THAT THERE WAS BLOOD LOSS OF 3-4 ML. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274360 ↗
• MalfunctionJun 28, 2018Hole In Material; Hole In Material

  ACCORDING TO THE REPORTER, AFTER THE DOCTOR COMPLETED THE SURGERY AND THE CATHETER WAS IMPLANTED INTO THE PATIENT, THE DOCTOR PRE-EXPANDED THE CATHETER TO TEST IF IT IS SMOOTHLY FLOWING, BUT THE POSITION OF THE EPITAXIAL TUBE AND JOINT WAS CRACKED WHEN PRE-EXPANDED. IT WAS ALSO STATED THAT THE DOCTOR FLUSHED THE CATHETER WITH SALT WATER AND AFTER REPEATED SUCTIONING, THE POSITION OF THE PIPE JOINT AND EPITAXIAL TUBE WAS BROKEN. IT WAS ALSO REPORTED THAT THE CATHETER HAS A LEAK AT THE LUER JOINT AND TRANSPARENT EXTENSION PIPE JOINT. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648717 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1316-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.