MAHURKAR 8888345629HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521128163), received between Nov 30, 2017 and Jul 1, 2025 — classified as 6 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 (K102605, 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-2389-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER DETACHED FROM THE FIXATION PLATE AND THE RING. IT WAS ALSO STATED THAT THE CATHETER LOST ITS FIXATION PLATE. THERE WAS NO LEAK. A TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22378839 ↗
• MalfunctionAug 5, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, IT APPEARS THAT THERE WAS A WELD ON THE THIRD LUMEN, WHICH HAS BECOME BROKEN. THE WELD PART ON THE THIRD LUMEN SEEMS TO BE A FRACTURE POINT. THE REMEDIAL ACTION PERFORMED WAS TO REMOVE THE CATHETER. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO LEAK. THE CATHETER WAS NOT REPAIRED. THE PRODUCT WAS NOT REPLACED. NOTHING UNUSUAL IS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DAMAGE WAS FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE USE ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE. 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 19912416 ↗
• MalfunctionJan 5, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, LEAKING WAS NOTED UNDER THE CATHETER'S DRESSING IN THE RIGHT FEMORAL VEIN, THE DRESSING WAS TAKEN DOWN, AND A TINY PUNCTURE WAS NOTED IN THE BLUE LUMEN OF THE CATHETER. IT DID NOT COMPROMISE THE USE OF DIALYSIS, ALTHOUGH FOR THE SAFETY OF THE PATIENT, THE LINE WAS MONITORED CLOSELY. IT WAS ALSO STATED THAT THE INTENDED PROCEDURE WAS HEMODIALYSIS. THE APPROXIMATE AGE OF DEVICE WAS 10 DAYS. DIALYSIS WAS STOPPED THE NEXT DAY, AND A NEW CATHETER WAS OBTAINED. THE ORIGINAL CATHETER WAS REMOVED. THEREWAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18457011 ↗
• MalfunctionAug 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A LINE WAS USED FOR REGULAR ACCESS DURING HOSPITALIZATION, FLUSHING, MEDICATION ADMINISTRATION, AND LAB DRAWS. HOWEVER, FIVE DAYS AFTER INSERTION, AT THE TIME OF REMOVAL OF THE TEMPORARY DIALYSIS CATHETER IN THE OPERATING ROOM (OR), UPON ASSESSMENT (PRIOR TO REMOVAL), THE END PIECE (OR THE LUER ADAPTER OF THE THIRD PORT) WAS MISSING, WHICH COULD LEAD TO A RISK OF INFECTION. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK. ALCOHOL WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. NO OINTMENT WAS APPLIED. THE DEVICE WAS FLUSHED WITH A CONCENTRATED HEPARIN SOLUTION AND SHOWED ADEQUATE FUNCTION. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED, AND THEY WERE NOT AWARE OF PREVIOUS CATHETER REPAIRS. THE PRODUCT WAS NOT REPLACED. NO REMEDIAL ACTION WAS TAKEN; THE LINE WAS REMOVED BY THE SURGEON, AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAD A HISTORY OF PLACING A PRODUCT FROM THE SAME BRAND PREVIOUSLY FOR HEMODIALYSIS TREATMENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569484 ↗
• MalfunctionAug 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS NOTED TO BE LEAKING AT THE JUNCTION OF EXTENSION TUBES AND BIFURCATE DUE TO A FRACTURE IMMEDIATELY AFTER INSERTION (INTRA-OPERATIVELY) WHILE DRESSING WAS BEING APPLIED. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8853653 ↗
• MalfunctionNov 30, 2017Kinked; Kinked

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION THE GUIDE WIRE WAS BEING REMOVED FROM THE CATHETER AND HAD RESISTANCE WHEREIN AN INCREASED FORCE HAD TO BE USED TO PULL BACK THE WIRE. WHEN THE WIRE WAS COMPLETELY REMOVED, IT WAS FOUND TO BE TWISTED. AN X-RAY REVEALED THAT THE CATHETER WAS DOUBLE KINKED AND THAT PARTS OF THE GUIDE WIRE WERE VISIBLE INSIDE THE CATHETER. THE CATHETER WAS THEN COMPLETELY EXPLANTED, AND A NEW CATHETER WAS IMPLANTED TO RESOLVE THE ISSUE. THERE WAS NO INJURY TO THE PATIENT FROM THIS EVENT. IT WAS REPORTED 2 DAYS LATER THAT THE PATIENT HAD DIED, HOWEVER IT WAS NOT RELATED TO THE ISSUE WITH THE GUIDE WIRE. THE DOCTOR STATED THE DEATH WAS NOT CAUSED BY THE DEVICE. HE STATED THE CAUSE WAS THE SUM OF BASIC DISEASES OF THE PATIENT, A HIGH BLOOD LOSS DUE TO AN OPERATION PERFORMED, AND THE PATIENT HAD BEEN FAILING FOR WEEKS.

  Patient problems: Death

  MAUDE report 7072262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102605, K192302. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-2390-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
• Z-2377-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
• Z-2369-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
• Z-2375-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
• Z-2376-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
• Z-2385-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
• Z-2373-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
• 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-2388-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629

…and 16 more.