MAHURKAR 8888102004HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521128002), received between May 13, 2019 and Apr 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

30 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. Oct 17, 2025Class IIOpen, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0425-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2372-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING INSERTION OF DIALYSIS LINE, SLOW LEAK/CRACK WAS NOTED ON WHITE PLASTIC OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183313 ↗
• MalfunctionMay 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IMPLANTED TO THE PATIENT FOR 5 DAYS AND WHEN TRYING TO USE IT (DIALYSIS WAS RUNNING THROUGH THE DIALYSIS LUMENS), THE THIRD PORT (PIGTAIL) WAS NOT PULLED ON BUT THE THIRD PORT APPEARED TO HAVE JUST COME OFF THE PIGTAIL. NONE OF THE LINES WERE DISPLACED WHICH WE WOULD OCCUR IF PULLED ON HARD ENOUGH TO PULL OFF A HUB TO THE PIGTAIL PORT. IT WAS MENTIONED THAT THE TUBING WAS UNDER THE PATIENT'S HEAD WHICH PROBABLY HELPED TO SECURE THE LINE IN PLACE. ALCOHOL AND CHLORHEXIDINE GLUCONATE (CHG) WAS USED AS CLEANING AGENTS ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THEY ALSO UTILIZED 70% IPA CAPS AND NORMAL TWIST WAS UTILIZED TO TIGHTEN THE THIRD PORT. AS THE PATIENT WAS TOO UNSTABLE, A NEW PRODUCT WAS PLACED ON (B)(6) 2022 (TUNNELED HEMODIALYSIS LINE PLACED IN INTERVENTIONAL RADIOLOGY/IR) TO RESOLVE THE ISSUE. THE CATHETER WAS NOT REPAIRED, IT WAS CLAMPED UNTIL IT COULD BE REPLACED, NO REPAIR WAS ATTEMPTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489948 ↗
• MalfunctionMay 13, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING TREATMENT FOR CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY), LINE WAS PLACED WITHOUT INCIDENT, AND WAS CONFIRMED WITH US (ULTRASOUND), AS PER THE RESIDENT PERFORMING THE PROCEDURE, THERE WAS NO RESISTANCE TO INSERTING THE WIRE. HOWEVER, WHEN THEY TRIED TO REMOVE THE WIRE, THEY ARE UNABLE TO REMOVE IT. IT WAS STATED THAT THE GUIDE WIRE THAT CAME WITH THE KIT WAS USED. THEY CALLED A VASCULAR SURGEON FOR ASSISTANCE WHO WAS ULTIMATELY ABLE TO REMOVE THE WIRE WHICH WAS KINKED. THE GUIDE WIRE AND CATHETER WAS REMOVED AS ONE PIECE AFTER THEY TRIED TO MANIPULATE THE CATHETER AND GUIDE WIRE, THE WIRE CAME OUT INTACT AND IT WAS STATED THAT IT WAS A FEMORAL LINE. NO TOOLS WAS USED TO REMOVE THE WIRE, BUT WAS STATED THAT SOME FORCE WAS NEEDED BUT NO EXCESSIVE. IT WAS STATED THAT THE WIRE WAS TOO FLIMSY TO PLACE IN A LINE, ESPECIALLY ON A DIALYSIS LINE WHICH REQUIRED MULTIPLE DILATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604574 ↗

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-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-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-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-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-2383-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
• Z-2367-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
• 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-2387-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
• 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
• 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-2388-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
• Z-2378-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
• Z-2380-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
• Z-2391-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP

…and 15 more.