MAHURKAR 8888102003HP (UDI 10884521127999)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521127999), received between Feb 5, 2020 and Dec 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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-0424-2026 · 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-2371-2023 · 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.

• MalfunctionDec 7, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Contamination /Decontamination Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER. ONCE THEY COMPLETED THE PLACEMENT OF THE LINE THEY WAS ABLE TO DRAW BACK ENOUGH BLOOD TO GIVE THE NURSE FOR LABS. UPON TRYING TO ASPIRATE AGAIN AFTER SUTURES WERE PLACED THE LINE DID NOT RETURN ANY BLOOD. THE DAY AFTER IMPLANT WAS UNABLE TO DRAW BACK BLOOD AND THE COLLEAGUE WENT TO EXCHANGE THE LINE, THE DEVICE WAS REMOVED AND FOUND THAT THE TIP OF THE CATHETER HAD SOME ADHERENT IN THE TUBE. IT WAS MENTIONED THAT THEY RECALLED THE STEPS PRIOR TO PLACING THE LINE. AS WITH THE STANDARD OF PRACTICE ONCE THE PATIENT WAS DRAPED, THEY STARTED BY SETTING UP THE CENTRAL LINE EQUIPMENT IN THE CORRECT ORDER. AS PERSONAL PRACTICE THEY FIRST FLUSH THE LINE AFTER CONNECTING THE CAPS AND FLUSHING ALL LINE, THEN THEY LINED UP THE REMAINDER OF THE EQUIPMENT IN THE CORRECT ORDER FOR A SELDINGER TECHNIQUE THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18285110 ↗
• MalfunctionOct 31, 2023Product Quality Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Product Quality Problem; Insufficient Flow or Under Infusion; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CATHETER WAS PLACED APPROPRIATELY BUT WAS UNABLE TO DRAW BACK FLOW AFTER PLACEMENT. THE WIRE WAS ABLE TO PROCEED RETROGRADE (CATHETER ADVANCED OVER WIRE) DURING PLACEMENT. HOWEVER, WHEN THEY ATTEMPTED TO REWIRE AND EXCHANGE FOR A 20 CENTIMETER CATHETER, THE NEW 0.35 GUIDEWIRE WAS UNABLE TO ADVANCE ANTEGRADE (THROUGH CATHETER FROM PORT TO TIP). WHEN THE DEVICE WAS REMOVED, THEY ATTEMPTED TO PASS THE WIRE EXTERNALLY. IT WAS ABLE TO PASS RETROGRADE (TIP TO PORT), BUT NOT ANTEGRADE (PORT TO TIP). IT APPEARED THE "J" TIP WAS GETTING CAUGHT TOWARDS THE DISTAL END OF THE CATHETER. IT WAS MENTIONED THAT THE ISSUE WAS THAT THE CATHETER WAS OCCLUDED BASED STRICTLY OFF OF THE PHYSICIANS WHERE THE CATHETER COULD NOT PASS OVER WIRE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THEY RECALLED THE STEPS PRIOR TO PLACING THE LINE. AS WITH THE STANDARD OF PRACTICE ONE THE PATIENT WAS DRAPED, THEY STARTED BY SETTING UP THE CENTRAL LINE EQUIPME NT IN THE CORRECT ORDER. AS PERSONAL PRACTICE THEY FIRST FLUSH THE LINE AFTER CONNECTING THE CAPS AND FLUSHING ALL LINE, THEN THEY LINED UP THE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038723 ↗
• MalfunctionDec 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE HUB OF THE CATHETER'S EXTERNAL PORTION (DISTAL END OR PIGTAIL) WAS DISCONNECTED FROM THE LUMEN, WHICH RESULTED IN THE LUMEN BEING OPEN TO THE ATMOSPHERE. THE NURSE WAS NOT AWARE OF ANY TENSION OR PULLING OF THE LINE THAT WOULD HAVE CAUSED IT TO DISCONNECT. THERE WAS NO BLOOD LOOS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, ROUTINE CARE INCLUDING FLUSHING PRE/POST INFUSIONS WAS PERFORMED AND NO IMMEDIATELY ACTION WAS TAKEN PRIOR TO THE IDENTIFIED EVENT. IT WAS ALSO MENTIONED THAT SORBAVIEW DRESSING, BIOPATCH, PREVANTICS WIPES, CUROS CAPS WAS UTILIZED WITH THE DEVICE, THERE WAS NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED, CHLORHEXIDINE GLUCONATE (CHG) WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT, THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED, THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT AND NO AIR EMBOLISM HAPPENED. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE JUNCTION OF EXTENSION TUBE AND BIFURCATE, THERE WAS NO CLEANING AGENT USED ON THE DEVICE PRIOR TO THE INCIDENT, TEGO WAS NOT UTILIZED, THERE WAS NO LUER A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017687 ↗
• MalfunctionFeb 5, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A SMALL HOLE AT THE BASE OF THE BLUE PORT. IT WAS ALSO STATED THAT THERE WAS NO AIR REACHED TO THE PATIENT AS THE AIR WAS BEING SUCTIONED INTO THE CATHETER LINE THROUGH THE HOLE IN ROUTE TO THE CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY). IT WAS ALSO NOTED THAT DURING INITIATING THE CRRT THERAPY, AIR KEPT GETTING INTO THE LINE THAT WAS TAKING BLOOD FROM PATIENT TO CRRT MACHINE FILTER. THREE FILTERS WERE CHANGED OUT, RE-PRIMED AND RESTARTED WITH THE SAME RESULTS. WHEN THE 3RD FILTER WAS INITIATED, A SMALL AMOUNT OF BLOOD WAS NOTED ON THE TOWEL LYING UNDERNEATH THE HD (HEMODIALYSIS) CATHETER. IT WAS ALSO MENTIONED THAT THERE WAS A LEAK AND THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9674207 ↗

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-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-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-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-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-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-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-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-2384-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
• 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-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-2378-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629

…and 15 more.