MAHURKAR 8888135192Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521006478), received between Mar 15, 2019 and Aug 15, 2025 — 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.

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.

• MalfunctionAug 15, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE CATHETER WAS INSERTED, IT WAS WITHOUT COMPLICATIONS, BUT WHEN REMOVING OR WITHDRAWING THE GUIDE, IT WAS OBSERVED THAT IT PRESENTED RESISTANCE TO EXIT, SO FORCE WAS USED TO TRY TO REMOVE THE GUIDE. THIS ATTEMPT WAS MADE SEVERAL TIMES, AND WHEN REMOVING THE GUIDE, IT WAS OBSERVED THAT IT WAS FRAYED AND SEEN TO BE SPLIT IN SOME PARTS. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. CLORHEXIDINA WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED BY HAND. UPON NOTICING THAT THE GUIDEWIRE WOULD NOT COME OUT, AS A REMEDIAL ACTION, IT WAS NECESSARY TO REMOVE THE ENTIRE CATHETER WITH THE GUIDEWIRE STILL INSIDE (INTACT). NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS NO BLOOD LOSS, AND THERE WAS NO BLOOD TRANSFUSION DUE TO THE EVENT. THE EVENT DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822252 ↗
• MalfunctionMar 15, 2019Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, ON INSERTION OF THE CATHETER, THE GUIDE WIRE WAS "FRACTURED". THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426142 ↗

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-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-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-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-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