MAHURKAR 8888345611HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521128149), received between Nov 25, 2019 and Aug 5, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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-2387-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, IT APPEARS THAT THERE WAS A WELD ON THE THIRD LUMEN, WHICH HAS BECOME BROKEN. THE WELD PART ON THE THIRD LUMEN SEEMS TO BE A FRACTURE POINT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. AS A REMEDIAL ACTION, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NOTHING UNUSUAL IS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE USE ON THE DEVICE. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912501 ↗
• MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, IT APPEARS THAT THERE WAS A WELD ON THE THIRD LUMEN, WHICH HAS BECOME BROKEN. THE WELD PART ON THE THIRD LUMEN SEEMS TO BE A FRACTURE POINT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. AS A REMEDIAL ACTION, THE CATHETER WAS REMOVED. NOTHING UNUSUAL IS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE USE ON THE DEVICE. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912068 ↗
• MalfunctionMay 24, 2022Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS BEING MOVED INTO THE CT (COMPUTED TOMOGRAPHY) SCANNER, THE LINES TO THE INFUSION LUMEN OF TEMPORARY CATHETER WERE SNAGGED RESULTING IN THE LUMEN TO FRACTURE OFF. THE EVENT INVOLVED A SEASONED ICU RN (INTENSIVE CARE UNIT ¿ REGISTERED NURSE) AND IR (INTERVENTIONAL RADIOLOGIST) FELLOW WHICH IS ATYPICAL. THE CATHETER WAS NOT REPAIRED. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490317 ↗
• MalfunctionMay 4, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A CRACK FOUND IN LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14273907 ↗
• MalfunctionNov 18, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE THE GUIDEWIRE WAS IN PATIENT AND CATHETER WAS BEING ADVANCED IN PATIENT, THERE WAS A RESISTANCE WITH THE GUIDEWIRE AND CATHETER. THE NURSE PRACTITIONER TRIED TO PULL THE WIRE BACK WHEN EXPERIENCING RESISTANCE AND DETERMINED THAT BOTH GUIDEWIRE AND CATHETER WERE STUCK. THE PATIENT WAS SUBSEQUENTLY SENT TO THE OPERATING ROOM TO HAVE FULLY GET CATHETER AND GUIDEWIRE OUT. UPON ADDITIONAL INSPECTION (AFTER PULLING OUT OF THE PATIENT), THE GUIDEWIRE WAS WRAPPED AROUND THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12836833 ↗
• MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING PATIENT CONNECTION, IT WAS STATED THAT THERE WAS AN AIR PRESENCE ALARM IN THE ARTERIAL CIRCUIT. THE SYRINGE WAS TESTED AND IT WAS POSITIVE FOR AIR PRESENCE. IT WAS MENTIONED THAT THE CATHETER WAS INSERTED ON (B)(6) THROUGH THE RIGHT INTERNAL JUGULAR. THERE WAS NOTHING UNUSUAL, NO VISIBLE DAMAGE WAS OBSERVED AND FLUSHING WAS DONE ON THE DEVICE BEFORE CONNECTING THE LINES. THE TREATMENT WAS STOPPED WITHOUT RESTITUTION AND THE CATHETER WAS CHANGE TO COMPLETE THAT PROCEDURE. CHLOREXYDINE ALCOOLIQUE WAS USED AS A CLEANING AGENT ON THE DEVICE AND BISEPTINE FOR THE PATIENT'S SKIN. THERE WAS NO LEAK/BREAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS, NO BLOOD TRANSFUSION GIVEN AND IT WAS STATED THAT THE EVENT DID NOT LEAD TO AN EXTENDED HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9369774 ↗

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

…and 16 more.