MAHURKAR Elite 8888222216Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521125834), received between Nov 3, 2020 and Aug 1, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN INSERTING THE GUIDEWIRE, IT GETS STUCK IN THE CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22690157 ↗
• MalfunctionApr 28, 2025Unraveled Material; Premature Indicator Activation; Unraveled Material; Premature Indicator Activation

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, INSTEAD OF THE INCLUDED 18G PUNCTURE NEEDLE, ANOTHER 18G CANNULA NEEDLE WAS PREPARED AND USED TO PUNCTURE IT. HOWEVER, THE GUIDEWIRE DID NOT PASS THROUGH, SO A 16G CANNULA NEEDLE WAS USED AND THE PROCEDURE WAS CONTINUED. THE GUIDEWIRE PASSED THROUGH THE CANNULA NEEDLE, BUT IT DID NOT COME OUT ANYMORE. WHEN A SMALL AMOUNT OF FORCE WAS APPLIED TO PULL IT OUT, THE COILED GUIDEWIRE WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917755 ↗
• MalfunctionSep 8, 2022Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS PLACED AND THE DIALYSIS WAS STARTED, A DEFECT EVENT OCCURRED IN WHICH BLOOD LEAKED (UNKNOWN ML) FROM THE CATHETER INSERTION/PUNCTURE SITE. IT WAS SAID THAT THERE WAS A POSSIBILITY OF CATHETER DAMAGE (MALFUNCTION) AT THE SUBCUTANEOUS PLACEMENT SITE OF THE CATHETER. THE CATHETER TIP HAD BEEN CUT IN THE HOSPITAL IN ORDER TO BE USED FOR CULTURE. IT WAS SAID THAT THE IMPLANT DATE OF THE REPORTED CATHETER WAS SAME WITH THE EVENT DATE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULTS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD TRANSFUSION REQUIRED. IT WAS SAID THAT THE PATIENT HAD CATHETER REMOVAL TO RESOLVE THE ISSUE AND WAS NOT REPLACED. TREATMENT WAS NOT COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379950 ↗
• MalfunctionJan 18, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT (AFTER PLACING A SAMPLE IN THE RIGHT INTERNAL JUGULAR VEIN), A CRACK LIKE CRUSHING WAS FOUND NEAR THE CURVE OF THE A SIDE BRANCH TUBE BUT IT WAS JUDGED ON THE SPOT THAT THERE WAS NO INFLUENCE, SO IT WAS NOW STILL IN USE. NO PROBLEM SUCH AS LEAKAGE HAD OCCURRED SO FAR. NO PROBLEMS HAVE OCCURRED SINCE THE IMPLANTATION. IT WAS SAID THAT AT THE SAME TIME OF THE EVENT, THEY OPENED AND CHECKED ANOTHER PRODUCT (SECOND PRODUCT, NOT USED) FROM THE SAME LOT JUST TO BE SURE AND THE SAME PROBLEM (CRACK LIKE CRUSHING) WAS FOUND NEAR THE CURVE OF THE A SIDE BRANCH TUBE. THE CATHETER WAS NOT REPAIRED. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CLAMP WAS NOT MOVED PERIODICALLY. NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11187773 ↗
• MalfunctionJan 18, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT (AFTER PLACING A SAMPLE IN THE RIGHT INTERNAL JUGULAR VEIN), A CRACK LIKE CRUSHING WAS FOUND NEAR THE CURVE OF THE A SIDE BRANCH TUBE BUT IT WAS JUDGED ON THE SPOT THAT THERE WAS NO INFLUENCE, SO IT WAS NOW STILL IN USE. NO PROBLEM SUCH AS LEAKAGE HAD OCCURRED SO FAR. NO PROBLEMS HAVE OCCURRED SINCE THE IMPLANTATION. IT WAS SAID THAT AT THE SAME TIME OF THE EVENT, THEY OPENED AND CHECKED ANOTHER PRODUCT (SECOND PRODUCT, NOT USED) FROM THE SAME LOT JUST TO BE SURE AND THE SAME PROBLEM (CRACK LIKE CRUSHING) WAS FOUND NEAR THE CURVE OF THE A SIDE BRANCH TUBE. THE CATHETER WAS NOT REPAIRED. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CLAMP WAS NOT MOVED PERIODICALLY. NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11186373 ↗
• MalfunctionNov 3, 2020Material Frayed; Infusion or Flow Problem; Material Frayed; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THE CATHETER HAD FLOW PROBLEMS, USUALLY AFTER SECOND DIALYSIS THE CATHETER WAS NOT ABLE TO USE, LEADING TO FREQUENT CHANGES EVERY TWO DIALYSIS ON AVERAGE. THE GUIDE WIRE WAS NOT RIGID, MAKING IT DIFFICULT TO PASS, IN ADDITION TO RUPTURE IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10776987 ↗

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.