MAHURKAR 8888135194Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521006508), received between Feb 28, 2019 and Sep 16, 2021 — classified as 1 injury, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K030209, 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. Dec 7, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-0877-2023 · Root cause: Process design · 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.

• MalfunctionSep 16, 2021Break; Break

  ACCORDING TO THE REPORTER, ON AUG 26, IT WAS SAID THAT THE PATIENT HAD A CATHETER LINE PLACEMENT. ON AUG 29 AT 20:00, BLOOD LEAKAGE WAS NOTICED FROM THE BIFURCATE OF THE DUAL LUMEN CATHETER. THE DOCTOR INSPECTED THE CATHETER AND NOTICED THAT THERE WERE CIRCULAR CRACK AROUND THE CATHETER - BIFURCATE (WHITE EXTERNAL PORTION), HOWEVER, THE DOCTOR DID NOT SAVE THE CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. ON AUG 30, THE CATHETER WAS REMOVED AND REPLACED AS INTERVENTION DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481054 ↗
• InjuryFeb 28, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, CLINICIAN STATED THAT THERE WAS A DIFFERENCE OF .6ML BETWEEN THE PRINTED PRIMING VOLUME AND THE ACTUAL LUMEN CAPACITY, THE PATIENT WAS GIVEN WITH 5000 UNITS OF HEPARIN PER ML, THIS GAVE THE PATIENT WHO HAD EMBOLIC STROKE 3000 UNITS THAT WENT SYSTEMIC THUS INCREASING THE RISK OF A HEMORRHAGIC STROKE, THE PATIENT SPENT A COUPLE OF DAYS IN THE INTENSIVE CARE UNIT(ICU) (INTENSIVE CARE UNIT) AS HEPARIN BOLUS WAS A MAJOR FACTOR FOR THE EXTENDED STAY, PATIENTS' ICU STAY WAS INITIALLY FOR EMBOLIC STROKE INTERVENTION. IT WAS STATED THAT PRIMING VOLUME PRINTED ON THE CATHETER AND IN THE IFU IS 1.6 ML ON THE ARTERIAL (RED) LUMEN AND 1.7 ML ON THE VENOUS (BLUE) LUMEN WAS NOT ACCURATE. IT WAS ALSO STATED THAT THE "ACTUAL" VOLUME THAT THE CATHETER LUMENS HOLD IS LESS THAN PRINTED IN THE IFU (INSTRUCTIONS FOR USE) AND ON THE CATHETER, TESTED PRIMING VOLUMES WERE OVER BY ABOUT .4-.6ML. IT WAS REPLACED WITH A COMPETITORS PRODUCT. THERE WAS NO REPORTED PATIENT HARM AND THE PATIENT WAS DISCHARGED AFTER 1-2 DAYS OF ADDITIONAL OBSERVATION FROM THE ICU.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8380042 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030209, 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-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-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-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-1955-2019 · Apr 29, 2019 · Terminated
  MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 88156
• Z-0233-04 · Dec 2, 2003 · Terminated
  Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192
• Z-0234-04 · Dec 2, 2003 · Terminated
  Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195