MAHURKAR Elite 8888221320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521126381), received between Jan 2, 2019 and Jan 2, 2024 — classified as 3 injuries.

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.

• InjuryJan 2, 2024Product Quality Problem; Unraveled Material; Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE OF INSERTING THE REPORTED CATHETER, THE RESIDENT ADVANCED THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE TO THE 10CM (CENTIMETER) MARK AND THEN HAD RESISTANCE TO ADVANCE IT FURTHER. THE RESIDENT PULLED BACK ON THE GUIDEWIRE AND THE GUIDEWIRE UNRAVELED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO PACKAGING DAMAGE OBSERVED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CUSTOMER UTILIZED THE CHLORAPREP SWABS INCLUDED IN THE TRAY TO CLEAN THE INSERTION SITE. THE CUSTOMER HAD THE WIRE AND THE PACKAGES. THE CATHETER WAS NOT REPAIRED. THE PATIENT RECEIVED AN X-RAY TO CONFIRM THAT NO PARTICLES WERE LEFT IN THE PATIENT. NONE WERE FOUND AND NO PATIENT INJURY WAS REPORTED. AS A REMEDIAL ACTION A NEW DUAL LUMEN CATHETER WAS PLACED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18432154 ↗
• InjuryJun 30, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, THE ANESTHESIA RESIDENT ATTEMPTED TO PLACE DUAL LUMEN DIALYSIS CATHETER IN THE RIGHT FEMORAL VEIN UNDER FELLOW GUIDANCE OF A DOCTOR. THE VEIN WAS EASILY CANNULATED, AND THE GUIDE WIRE WAS EASILY PASSED. THERE WAS NO ISSUE WITH THE DILATION AND THE CATHETER WAS THREADED OVER THE WIRE WITHOUT ISSUE. HOWEVER, WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE, A KINK WAS EVIDENT. THE CATHETER WAS PULLED BACK A FEW CENTIMETERS AND WAS ABLE TO THREAD THE KINK THROUGH THE CATHETER. THE CATHETER WAS RE-ADVANCED WITHOUT ISSUE. THERE WAS AN ATTEMPT TO REMOVE THE GUIDEWIRE AGAIN, AT WHICH POINT THE GUIDEWIRE APPEARED TO BE DAMAGED WITH INNER COILS VISIBLE AND UNCOILED. AT THAT TIME, THE PATIENT WAS NOTED TO BE BRADYCARDIC AND HYPOTENSIVE. THE ENTIRE CATHETER AND GUIDEWIRE WERE REMOVED, AND THE PRESSURE WAS HELD TO THE GROIN. SINCE THE SITE WAS FULLY DILATED THERE WAS SOME OOZING OF BLOOD. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED, AND THE CATHETER WAS NOT REPAIRED. THE PATIENT WAS STABILIZED WITH IVF (INTRAVENOUS FLUID) BOLUS. SUSPECTED VASOVAGAL REACTION. CXR (CHEST X-RAY) AND KUB (KIDNEY, URETER, AND BLADDER) WAS ORDERED TO ASSESS FOR REMAINING META

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Unintended Radiation Exposure

  MAUDE report 17236855 ↗
• InjuryJan 2, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THEY ATTEMPTED TO PULL THE WIRE, BUT THEY FELT A RESISTANCE, AND AS THEY WERE PULLING, THE GUIDE WIRE WAS STRETCHED OUT, SO THEY STOPPED AND PULLED THE WIRE AND THE CATHETER, THEY EXAMINED THE TIP OF THE WIRE AND CATHETER AND THEY WERE BOTH INTACT BUT NOTED THAT THE WIRE WAS STRETCHED A BIT. XRAY WAS DONE TO CHECK IF FOREIGN BODY WAS LEFT AND NOTHING WAS SEEN. A NEW CATHETER WAS INSERTED WITHOUT ANY ISSUES.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8208402 ↗

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.