MAHURKAR 8888345611Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521006782), received between Jun 20, 2018 and Sep 25, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 reports).

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

31 other recalls cover devices cleared under the same FDA submission (K020089, K192302); 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 28, 2023Class IOpen, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2386-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER PASSAGE WAS PERFORMED, AND IT WAS STATED THAT DURING THE TEST A LEAK WAS DETECTED IN THE EXTENSION OF THE THIRD ROUTE, BETWEEN THE ADAPTER AND LINE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20302770 ↗
• MalfunctionAug 26, 2024Misassembled; Misassembled

  ACCORDING TO THE REPORTER, THE TRIPLE LUMEN GUIDEWIRE WAS MISSING IN THE BOX. THE CATHETER WAS REPAIRED. THERE WAS NO LEAK. THERE WAS NO TEGO UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070943 ↗
• MalfunctionAug 13, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, WHILE INJECTING MEDICATION THROUGH THE MEDIAL LINE OF THE TRIPLE LUMEN CATHETER KIT, IT WAS O BSERVED THAT THERE WAS LEAKAGE IN THE SILICONE TUBE OF THE CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE EXIT SITE. NORMAL SALINE WAS USED TO FLUSH THE CATHETER'S ARTERIAL AND VENOUS LINES. 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 19973844 ↗
• MalfunctionMar 28, 2024Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER SHAFT WAS SHOWING KINKING ISSUES. THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. A STERILE CLEANING AGENT WAS USED ON THE DEVICE, BUT IT WAS NOT USED TO TREAT THE INSERTION SITE PRIOR TO USE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE REPORTER FLUSHED THE LUMENS PRIOR TO USE, AND IT PASSED THROUGH THE CATHETER. THE CATHETER HAD BEEN IN PLACE FOR LESS THAN 3 MONTHS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE CATHETER WAS EXPLANTED TWO DAYS LATER. THEY WERE NOT ABLE TO COMPLETE THE TREATMENT AFTER THE REMEDIAL ACTION WAS DONE. NO INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000962 ↗
• MalfunctionJul 14, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, RIGHT AFTER THE CATHETER IMPLANTATION ON THE DAY OF THE EVENT, THE CATHETER HAD A LEAKAGE IN THE THIRD LUMEN. THE LEAK WAS LOCATED AT THE JUNCTION OF THE THIRD PORT (MIDDLE) OF THE EXTENSION TUBE AND BIFURCATE. THE CATHETER WAS NOT REPAIRED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS POVIDONE IODINE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, A NEW CATHETER WAS INSERTED ON THE SAME DAY OF THE EVENT. THERE WAS A BLOOD LOSS OF 1-2 ML (MILLILITERS) AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330434 ↗
• MalfunctionAug 10, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDE WIRE CAME APART. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, THERE WAS NO LUER ADAPTER ISSUE, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND THE EVENT DID NOT LEAD TO OR EXTEND THE PATIENT'S HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201561 ↗
• MalfunctionOct 25, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT TWO DAYS AFTER THE CATHETER WAS IMPLANTED, THE CATHETER WAS NOT WORKING PROPERLY (BLOCKED). THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. FLUSHINGWAS DONE AND IT WENT WELL, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CUSTOMER TRIED TO REVERSE THE LINES BUT THERE WAS NO FLOW OBSERVED. IT WAS ALSO MENTIONED THAT THERE WAS NO OTHER ISSUE ASIDE FROM THE CATHETER BEING BLOCKED. THE DEFECTIVE CATHETER WAS EXPLANTED AND A NEW ONE WAS IMPLANTED (CATHETER REPLACEMENT) TO RESOLVE THE ISSUE AND TREATMENT WAS COMPLETED. THERE WAS BLOOD LOSS OF ABOUT 10ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688925 ↗
• InjuryFeb 12, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING INSERTION, THE GUIDE WIRE GOT STUCK IN THE INSERTION/INTRODUCER NEEDLE CAUSING NO BACKFLOW. THE NEEDLE AND GUIDE WIRE WERE DEFECTIVE RESULTING IN FAILED PROCEDURE. THE GUIDE WIRE WAS REMOVED MANUALLY ALONG WITH THE INSERTION NEEDLE AT THE SAME TIME. NO TOOLS WERE USED TO REMOVE THE GUIDE WIRE. NO EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE GUIDE WIRE. WHEN REMOVED, THERE WAS NO VISUAL DAMAGE NOTED ON THE GUIDE WIRE. THE GUIDE WIRE WAS NOT FRAYED, COILED, OR UNRAVELED. X-RAY MACHINE WAS USED TO CHECK FOR RETAINED PIECE AND IT WAS DONE IN ADDITION TO GUIDE WIRE ISSUE. THE GUIDE WIRE DID NOT BREAK INTO PIECES. THE GUIDE WIRE WAS STILL INTACT. THE ISSUE WITH THE GUIDE WIRE WAS NOT NOTICED IN THE PACKAGING. THERE WAS RESISTANCE WHEN INSERTING THE GUIDEWIRE. THERE WAS NO VISIBLE DEFECT/DAMAGE NOTED WITH THE NEEDLE. THE GUIDE WIRE AND NEEDLE USED WERE THE ONES INCLUDED IN THE KIT. THE DIMENSION(S) OF THE NEEDLE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO DAMAGE TO THE DEVICE'S BOX OR PACKAGING. THE PRODUCT/KIT WAS STILL SEALED UPON RECEIPT OF THE CUSTOMER. NO EXCESSIVE FORCE WAS USED TO PULL/TAKE OUT THE PRODUCT. IT WAS STATED

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11322112 ↗
• MalfunctionAug 18, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS SESSION, LEAKING WAS OBSERVED FROM THE CATHETER SHAFT AT THE JUNCTION OF BIFURCATE AND CATHETER. THERE WAS NOTHING UNUSUAL OBSERVED PRIOR TO USE AND THERE WERE NO DEFECTS/DAMAGES NOTED ON THE DEVICE DURING VISUAL INSPECTION, AND THERE WAS NO ISSUE ON FLUSHING PRIOR TO TREATMENT. THEY REMOVED THE CATHETER AND REPLACED WITH ANOTHER PRODUCT (SIMILAR MODEL) AND THE DIALYSIS SESSION WAS COMPLETED. THERE WAS A BLOOD LOSS OF LESS THAN 2ML, BLOOD TRANSFUSION WAS NOT REQUIRED. CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, BETADINE WAS USED TO CLEAN THE DEVICE, THERE WAS NO LUER ADAPTER ISSUE., THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10422625 ↗
• MalfunctionJul 3, 2018Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE, THE HEMODIALYSIS CATHETER WAS PASSED ON IN THE PATIENT. AFTER THE FIRST SESSION OF HEMODIALYSIS, IT PRESENTED INADEQUATE FLOW. IT WAS NECESSARY TO REPLACE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659019 ↗
• MalfunctionJun 20, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE COMMENCEMENT OF DIALYSIS WITH THE NEWLY INSERTED CATHETER, BLOOD WAS FOUND OOZING OUT FROM A TINY HOLE AT THE BLUE PORT. IT WAS STATED THAT THE LEAK WAS FOUND AT THE EXIT SITE. SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620214 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020089, K192302. One submission often covers many models, so check the product and lot details in each record.

• Z-0423-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-0421-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
• Z-0425-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0424-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-0426-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0422-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
• Z-2389-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
• Z-2383-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
• Z-2380-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
• Z-2382-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
• Z-2368-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
• Z-2372-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
• Z-2384-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
• Z-2371-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
• Z-2370-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP

…and 16 more.