MAHURKAR Elite 8888233220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521127685), received between Mar 7, 2024 and Sep 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K120674); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE INSERTION PROCEDURE, THE CUSTOMER INSTALLED THE CATHETER AND NOTICED BLOOD LEAKAGE IN THE EXTENSION PROXIMALLY UNDER THE CLAMP. IT HAPPENED AT THE ANESTHESIOLOGIST DEPARTMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS AN OBSERVATION OF FLUID LEAKAGE FROM THE CVK LEG (TRIPLE LUMEN CATHETER AND IT¿S THE MIDDLE LEG FOR I.V FLUIDS ) JUST INFERIOR TO THE LUER LOCK (LUER ADAPTER). THE LEAK WAS LOCATED JUST PROXIMAL FROM THE LUER ADAPTER. NO REPORT ON THE REASON FOR THE LEAKAGE. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE CATHETER WAS REPLACED WITH A CATHETER FROM THE SAME SUPPLIER. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE REMEDIAL ACTION PERFORMED WAS THE PLACEMENT OF A TRIPLE LUMEN DIALYSIS CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200945 ↗
• MalfunctionMar 8, 2024Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, BOTH CATHETERS HAD A PROBLEM WITH THE GUIDE SO IT COULD NOT INSERT THEM. IT WAS STATED THAT THE TWO CATHETERS WERE USED ON THE SAME PATIENT AND SAME DAY OF THE EVENT. WHEN THE CATHETER WANTED TO INSERT, THE PHYSICIAN TRIED TO FLUSH THE CATHETER TO PULL IT OVER THE GUIDEWIRE. HOWEVER, THE PHYSICIAN CANNOT USE THE THIRD LUMEN TO FLUSH AND TO PULL IN THE GUIDEWIRE. THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGE TO THE PRODUCTS AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. OCTENIDERM AND SODIUM CHLORIDE (NACL) WERE USED AS CLEANING AGENTS TO THE DEVICE. AS A REMEDIAL ACTION, A NEW CATHETER WITH THE SAME LOT WAS TAKEN. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18867703 ↗
• MalfunctionMar 7, 2024Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, BOTH CATHETERS HAD A PROBLEM WITH THE GUIDE SO IT COULD NOT INSERT THEM. IT WAS STATED THAT THE TWO CATHETERS WERE USED ON THE SAME PATIENT AND SAME DAY OF THE EVENT. WHEN THE CATHETER WANTED TO INSERT, THE PHYSICIAN TRIED TO FLUSH THE CATHETER TO PULL IT OVER THE GUIDEWIRE. HOWEVER, THE PHYSICIAN CANNOT USE THE THIRD LUMEN TO FLUSH AND TO PULL IN THE GUIDEWIRE. THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGE TO THE PRODUCTS AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. OCTENIDERM AND SODIUM CHLORIDE (NACL) WERE USED AS CLEANING AGENTS TO THE DEVICE. AS A REMEDIAL ACTION, A NEW CATHETER WITH THE SAME LOT WAS TAKEN. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18862302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120674. One submission often covers many models, so check the product and lot details in each record.

• Z-2319-2026 · Apr 29, 2026 · Open, Classified
  Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen
• Z-1007-2018 · Oct 14, 2017 · Terminated
  MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.