MAHURKAR 8888145252Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521014244), received between Jan 14, 2021 and Dec 30, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CATHETER HAD FLOW ISSUE, BLOOD WAS NOT COMING AND WAS BLOCKED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. SALINE WATER WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME LOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035578 ↗
• MalfunctionJul 24, 2024Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PRODUCT'S GRAY ELEMENT (WHICH THEY TEAR WHEN IMPLANTING THE CATHETER) ENDS WITH A NON-RETURN VALVE THAT PREVENTS BLOOD OUTFLOW (TRANSPARENT LATCH). UNFORTUNATELY, IT DID NOT FULFILL ITS FUNCTION, SO THERE WAS AN INTENSE OUTFLOW OF BLOOD THROUGH THE NON-RETURN VALVE ITSELF AT THE END OF THE TUNNEL OR GUIDEWIRE INTO WHICH THE ACTUAL VASCULAR CATHETER WAS INSERTED AND BELOW (BETWEEN THE GRAY, TEARABLE ELEMENT AND THE TRANSPARENT LATCH). THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE REPORTED PULL-APART SHEATH WAS THE ONE INCLUDED IN THE KIT. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. MASSIVE BLEEDING OCCURRED, AND IT WAS NECESSARY TO INTERRUPT THE PROCEDURE. THEY REMOVED THE ABOVE-MENTIONED ELEMENT. A NEW PRODUCT WAS OPENED AS REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE. NO CURRENT OR PRE-EXISTING CONDITION OF THE PATIENT THAT MIGHT BE RELATED TO THE EV ENT. THERE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817386 ↗
• MalfunctionJun 19, 2024Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN THE GUIDEWIRE PASSED FROM THE VENOUS LINE, THE HCP (HEALTHCARE PROFESSIONAL) NOTICED THAT THERE WAS SOME BLOCKAGE IN THE VENOUS LINE. THEY FOUND THAT THE LINE WAS BLOCKED AND THE GUIDEWIRE DID NOT PASS THROUGH THE CATHETER LINE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BETADINE WAS USED TO TREAT THE INSERTION SITE. FLUSHING WAS DONE WITH A NORMAL RESULT. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY DUE TO THE ALLEGED DEFECT. THERE WAS NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE GUIDE WIRE. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THE IMPLANT PROCEDURE WAS COMPLETED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER WITH ANOTHER CHRONIC CARBONATE CATHETER. THERE WAS NO INTERVENTION REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571044 ↗
• MalfunctionDec 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS TREATMENT, A CRACK WAS OBSERVED IN THE BLUE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO PRODUCT UTILIZED WITH THE DEVICE AND FLUSHING WAS PERFORMED WITH NORMAL RESULT. THERE WAS A LEAK AT THE LUER ADAPTER AND THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IT WAS ALSO STATED THAT OCTANISEPT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO CLEAN THE ADAPTERS. TEGO WAS UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE TREATMENT WAS PROCEEDED AND COMPLETED. THE BLOOD OF THE PATIENT WAS SAFELY RETURNED, AND THE CATHETER WAS NOT REPLACED BUT IT WAS REPAIRED BY HAND AS THE INTERVENTION/TREATMENT PROVIDED AS THE RESULT OF THE EVENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA (IN SOME PROCEDURE) AND THE DEVICE WAS SUCCESSFULLY USED AFTER IT WAS REPAIRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANS FUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072577 ↗
• MalfunctionDec 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE NORMAL HEMODIALYSIS PROCESS, A CRACK WAS OBSERVED IN THE BLUE LUER ADAPTER LOCK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND PRIMING WAS PERFORMED WITH NORMAL RESULT. THERE WAS A LEAK AT THE LUER ADAPTER AND THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IT WAS ALSO STATED THAT OCTANISEPT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO CLEAN THE ADAPTERS. TEGO WAS UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA. THE TREATMENT WAS PROCEEDED AND COMPLETED. THE DEVICE WAS SUCCESSFULLY USED AFTER IT WAS REPAIRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE END OF THE CATHETER WAS REPAIRED BY HAND AS THE INTERVENTION REQUIRED AS THE 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 16065332 ↗
• MalfunctionMay 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE HEMODIALYSIS PROCEDURE, A CRACK ON THE VENOUS (BLUE) LUER ADAPTER WAS OBSERVED AND HAD A LEAK. IT WAS NECESSARY TO EXPLANT THE CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE AND LUER ADAPTER WAS USUALLY TIGHTENED BY HAND. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND UTILIZED TO CLEAN THE ADAPTERS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND FLUSHING WAS DONE WITH GOOD RESULT. CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS EXPLANTED TO RESOLVE THE ISSUE AND AS THE INTERVENTION DONE AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463269 ↗
• MalfunctionMay 20, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS TREATMENT, A CRACK AND LEAK WERE OBSERVED ON THE BLUE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED, THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE, THERE WAS A LUER ADAPTER ISSUE, OCTANISEPT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO THE ADAPTERS. IT WAS NECESSARY TO EXPLANT THE CATHETER. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS EXPLANTED AS THE INTERVENTION/TREATMENT AS THE RESULT OF THE ADAPTER ISSUE, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED WITH NORMAL RESULT, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463133 ↗
• MalfunctionDec 30, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED ON THE PATIENT FOR MORE THAN 1 MONTH, DURING THE REMOVAL OF THE DRESSING AND SECURING THE CATHETER BEFORE CONNECTING INTO DIALYSIS, IT WAS NOTED THAT THE VENOUS LUER TIP/ADAPTER WAS DAMAGED (HAS A CRACK) AND LEAK WAS FOUND IN IT. THE ADAPTERS WERE USUALLY TIGHTENED BY HAND AND NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IT WAS MENTIONED THAT THERE WAS A SPECIAL PROCEDURE IN THE HOSPITAL (NO USE OF ANY INSTRUMENTS). TEGO WAS UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND IT WAS UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, PRIMING WAS COMPLETED WITH NORMAL RESULT AND NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE CATHETER EXTENSION WAS REPAIRED TO RESOLVE THE ISSUE. PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117888 ↗
• MalfunctionJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WASHING WITH A 10 CC SYRINGE AND SALINE SOLUTION ACCORDING TO THE PROTOCOL, THE BLUE LUER ADAPTER AND TEGO DETACHED FROM THE CATHETER EXTENSION LUMEN GENERATING BLOOD LOSS/LEAK OF LESS THAN 10 CC FROM THE CATHETER LUMEN EXTENSION AND CONNECTOR, THE LUMEN WAS IMMEDIATELY CLAMPED. CLEANING WITH CHLORHEXIDINE WAS PERFORMED AND THE CATHETER LUMEN WAS SEALED WITH A STERILE 1CC SYRINGE, COVERED WITH GAUZE AND FIXED TO THE SKIN. SALINE SOLUTION WAS ALSO USED AS A CLEANING AGENT ON THE DEVICE. THERE WERE NO OTHER DEFICIENT PRODUCTS USED DURING THE EVENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT TO EXTENDED PATIENT HOSPITALIZATION. THE PHYSICIAN WAS INFORMED, AND THE VASCULAR SURGEON ASSESSED THE PATIENT FOR A CATHETER CHANGE. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11172696 ↗

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.