MAHURKAR 8888101003HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521127975), received between Oct 5, 2023 and Jul 26, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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-0423-2026 · 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-2369-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE FEMORAL CATHETER WAS PLACED WITH ULTRASOUND GUIDANCE. THE PROCEDURE WENT AS EXPECTED UNTIL THE CATHETER WAS THREADED OVER THE WIRE AS DONE WITH THE SELDINGER TECHNIQUE. THE CATHETER WAS SUCCESSFULLY PLACED, BUT WHEN THE WIRE WAS WITHDRAWN THROUGH THE CATHETER, IT UNCOILED AND SNAPPED. IT WAS UNABLE TO BE SUCCESSFULLY WITHDRAWN. SURGERY AND IR WERE CONSULTED, AND THE PATIENT NOW HAVING TO UNDERGO A PROCEDURE TO HAVE SUCCESSFULLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19842856 ↗
• MalfunctionFeb 27, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE TEMPORARY DIALYSIS CATHETER WAS PLACED AND WHEN THE PIGTAIL LUMEN WAS FLUSHED, A HOLE WAS NOTED. THE PROCEDURE WAS EXTENDED TO REMOVE AND REPLACED THE PRODUCT WITH A NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793302 ↗
• MalfunctionOct 25, 2023Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE WIRE INCLUDED WITH THE CATHETER KIT CAME UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007180 ↗
• MalfunctionOct 5, 2023Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  ACCORDING TO THE REPORTER, DURING RIGHT FEMORAL DIALYSIS CATHETER INSERTION, THE GUIDEWIRE FRACTURED OR WAS SPLIT INTO THREE PIECES. IT ACTUALLY BROKE AS WELL AS UNRAVELED IN SEVERAL PLACES, FROM THE DISTAL END ALL THE WAY TO THE PROXIMAL END. THE NURSE SAID IT LOOKED LIKE A FRAYED ELECTRICAL CABLE. THE DOCTOR WAS ABLE TO GRAB IT WITH THE NEEDLE HOLDER AND PULL THE GUIDEWIRE OUT. IT WAS NOTED THAT THE GUIDEWIRE FRACTURE BECAME SPIRALS AFTER SERIAL DILATION AND ISOLATION OF THE GUIDE WIRE OR PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT IN THE SAME PROCEDURE. IT WAS NOTED THAT THE DIALYSIS CATHETER APPEARED TO BE POSITIONAL; THEREFORE, IT WAS SUTURED IN AN ADEQUATE POSITION, AND ALL THREE PORTS WERE FREE OR FLUSHING READILY. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO TEGO WAS UTILIZED, THERE WAS NO LUER ADAPTER ISSUE, AND THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE GUIDEWIRE. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THERE WAS NO DIMENSION ISSUE NOTED. THEY WERE NOT SURE IF THE DIMENSION OF THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL, AS THEY DID NOT CHECK. NO OTHER PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877240 ↗

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-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-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-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-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-2378-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
• Z-2381-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
• Z-2380-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
• Z-2384-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
• 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-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-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-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

…and 15 more.