MAHURKAR 8888340629HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521128071), received between Dec 17, 2019 and Jan 5, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 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-2379-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD A BROKEN TUBING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18461027 ↗
• MalfunctionJan 2, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN PROVIDERS WERE PLACING THE VASCULAR CATHETER IN THE PATIENT, THEY FLUSHED THE LINE BEFORE INSERTION AND NOTED A HOLE AT THE NECK OR THE SILICONE TUBING ON THE RED PORT. THE CATHETER WAS NOT INSERTED INTO THE PATIENT AFTER NOTING THE NORMAL SALINE LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO THE PROCEDURE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO COMPONENT OF THE KIT TOUCHED THE PATIENT'S SKIN. THE DEVICE NEVER REACHED THE PATIENT. A NEW VASCULAR CATHETER OF THE SAME PRODUCT ID (IDENTIFIER) AND LOT WAS OBTAINED, INSERTED ON SAME DATE AS THE COMPLAINT DATE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430161 ↗
• MalfunctionDec 18, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AT THE TIME OF THE EVENT THE CATHETER HAD BEEN IMPLANTED INTO THE PATIENT FOR 5 DAYS. DURING CVVHDF (CONTINUOUS VENO-VENOUS HEMODIAFILTRATION) TREATMENT, IT BEGAN TO ALERT PRESSURE ALARM WHEN CHANGING THE PATIENT'S POSITION. BY TWO NURSES, IT WAS DECIDED TO RINSE THE DIALYSIS CATHETER AND REPLACE THE VENOUS AND ARTERIAL LINES WITH THE IDEA THAT THE PRESSURE ALARM WOULD STOP. THEY WERE TRYING TO STOP THE ALARM AND TREATMENT COULD BE CONTINUED. BOTH LINES WERE FLUSHED AND AFTER THAT THOSE WERE VERY OPENED. HOWEVER, DURING CONNECTING, THE DIALYSIS CATHETER'S OWN CLOSURE/CLAMP BROKE THE ARTERIAL EXTENSION SILICONE SURFACE OF THE DIALYSIS CATHETER, MAKING A HOLE IN IT. IT WAS STATED THAT THERE WAS NO LEAK AT THE CATHETER SHAFT AND THE LEAK WAS ONLY LOCATED ATTHE ARTERIAL EXTENSION TUBE ABOUT 5 CM (CENTIMETER) FROM THE ADAPTER (LEAK/HOLE WAS LOCATED ABOUT IN THE MIDDLE OF THE EXTENSION TUBE) IN WHICH THE HOLE WAS ALSO OBSERVED. THE PATIENT'S BLOOD FROM THE HOLE WITH PRESSURE (THE PRESSURE IN THE CATHETER BLOOD SPLASHED TO TOP OF THE PATIENT) AND QUICKLY CLOSED THE DIALYSIS CATHETER WITH A CLOSING INSTRUMENT. THEY RETURNED THE BLOOD FROM A DIALYSIS DEVICE TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347137 ↗
• MalfunctionFeb 16, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PROCEDURE WAS COMPLETED AND THE CATHETER WAS PLACED PROPERLY IN THE PATIENT. UPON COMPLETION OF THE PLACEMENT, THE CATHETER WAS FLUSHED AND IT WAS DISCOVERED TO HAVE A LEAK IN THE EXTENSION TUBE. THE TEAM DID NOT REMEMBER WHICH EXTENSION TUBE WAS FLUSHED BUT THE LEAK CAME FROM THE SAME EXTENSION TUBE AS IF THERE WAS A LEAK SOMEWHERE ALONG THE EXTENSION TUBE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND IN THE PRODUCT WHERE THE LEAK WAS OBSERVED AND THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE CATHETER'S EXTENSION TUBE AND THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE CATHETER WAS REPLACED USING A DIFFERENT CATHETER FROM OUT PRODUCT AS THE INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16391697 ↗
• MalfunctionMay 24, 2022Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT WAS BEING MOVED OUT OF THE CT (COMPUTED TOMOGRAPHY) SCANNER WHEN THE LINES TO THE INFUSION LUMEN OF THE PATIENT'S TEMPORARY HEMODIALYSIS CATHETER WERE SNAGGED RESULTING IN THE LUMEN TO STRETCH AND THEN SNAPPED ACROSS HIS EAR LUER ADAPTER/THIRD PORT (PIG TAIL) WAS DETACHED/BROKE OFF FROM BEING SNAGGED. FORTUNATELY, IT CAUSED NO TRAUMA. HOWEVER, IT DID RESULT IN AN INTEGRAL FAILURE OF THE INFUSION LUMEN OF THE 3-LUMEN HEMODIALYSIS CATHETER REQUIRING ITS REPLACEMENT. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488563 ↗
• MalfunctionDec 13, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE AT NIGHT, THE PATIENT SAW A MICRO BLOOD LEAK BETWEEN BLUE LUER ADAPTER (CONNECTOR) AND IN THE END OF THE EXTENSION TUBE/LUMEN AND COVERED IT WITH A TRANSPARENT PLASTER (BLUE LUMEN HAD A DEFECTIVE GROMMET SEAL). THE CATHETER WAS NOT REPAIRED. ISOZID - FARBLOS (COLORLESS) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS AND TO THE ENTIRE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. IT WAS SAID THAT THE IMPLANT DATE FOR THE ACUTE CATHETER WAS APPROXIMATELY 2 OR 3 DAYS BEFORE BEING EXPLANTED ON (B)(6) 2021 AND DURING THE SAID IMPLANTATION, FLUSHING WAS DONE PRIOR WITH NORMAL RESULTS AND NOTHING UNUSUAL WAS ALSO OBSERVED ON THE DEVICE PRIOR TO USE. IT WAS ALSO SAID THAT THE INSERTION SITE WAS TREATED WITH ISOZID - FARBLOS (COLORLESS) PRIOR TO THE SAID PRODUCT PLACEMENT. THE CATHETER WAS THEN REPLACED ON THE SAME DAY OF THE EVENT WITH THE SAME TYPE OF CATHETER FROM THE SAME LOT NUMBER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984095 ↗
• MalfunctionAug 18, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS STATED THAT THE INFUSION SOLUTION SQUIRTED OUT OF THE RED (ARTERIAL) EXTENSION TUBE BETWEEN THE CLAMP AND THE ULTEM ADAPTER WHEN THE INFUSION WAS RAPID (THE DEFECT WAS NOT VISIBLE TO THE NAKED EYE). THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. FLUSHING WAS DONE BEFORE THE PROCEDURE AND NOTHING FOUND. THE CATHETER WAS NOT REPAIRED. THERE WAS NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE, TYPICALLY IN THE ADAPTERS AND ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WERE NO OTHER FAULTS FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW SAME TYPE. THE TREATMENT WAS COMPLETED BUT ONLY FOR TWELVE HOURS. THE CATHETER WAS RINSED IN THE ICU AND AT THAT MOMENT, IT FLUSHED A LITTLE BIT WITH STERILE NACL (SODIUM CHLORIDE) OUTSIDE ON THE FLAW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340307 ↗
• MalfunctionDec 17, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A CRACK AT THE END OF THE EXTENSION TUBE NEAR TO THE BLUE CONNECTOR. IT WAS ALSO STATED THAT WHEN THE PATIENT WAS REARRANGED, THEY SAW A BLOOD SPOT UNDER THE PATIENT. WHEN THE PATIENT WAS LIFTED, BLOOD FOUNTAIN CAME OUT OF THE CRACK. THERE WAS BLOOD LOSS OF APPROXIMATELY 150ML AND NO TRANSFUSION WAS DONE. TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED AND WAS THEN REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481386 ↗

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-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-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-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-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-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-2388-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
• 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-2374-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
• Z-2378-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
• 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-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-2384-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603

…and 16 more.