MAHURKAR 8888345637Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521006829), received between Mar 26, 2018 and Aug 27, 2019 — classified as 2 malfunctions.

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

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-2390-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, LEAK WAS NOTED ON THE ARTERIAL SCREW THREAD (LUER ADAPTER) PORTION. IT WAS ALSO MENTIONED THAT A LOT OF AIR WAS PRESENT IN THE SYRINGE. THE CATHETER WAS NOT REPAIRED, AND NO CLEANING AGENT WAS USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934597 ↗
• MalfunctionMar 26, 2018Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE RETRACTION OF THE CATHETER, THE DOCTOR EXPERIENCED DIFFICULTY TO REMOVE THE GUIDEWIRE AFTER INSERTION OF THE CATHETER. THE DOCTOR EVENTUALLY HAD TO REMOVE THE CATHETER TOGETHER WITH THE GUIDEWIRE. UPON CHECKING THE GUIDEWIRE, IT WAS FOUND TO BE BROKEN AND SPLIT INTO THREE (3) PARTS. THE COILED PORTION WAS INTACT. A NEW CATHETER WAS INSERTED TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7369973 ↗

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-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-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-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-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-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-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-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-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-2391-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
• 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-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-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

…and 16 more.