MAHURKAR 8888145003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521014183), received between Sep 8, 2017 and Jul 24, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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

2 other recalls cover devices cleared under the same FDA submission (K111372); 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. Jun 8, 2022Class IOpen, Classified

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

   Z-1320-2022 · Root cause: Process control · 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.

• MalfunctionJul 24, 2024Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PULL-APART SHEATH, WHICH WAS THE PRODUCT'S GRAY ELEMENT (WHICH THEY TEAR WHEN IMPLANTING THE CATHETER), ENDS WITH A NON-RETURN VALVE THAT PREVENTS BLOOD OUTFLOW (TRANSPARENT LATCH). UNFORTUNATELY, IT DID NOT FULFILL ITS FUNCTION, SO THERE WAS AN INTENSE OUTFLOW OF BLOOD THROUGH THE NON-RETURN VALVE ITSELF AT THE END OF THE TUNNEL OR GUIDEWIRE INTO WHICH THE ACTUAL VASCULAR CATHETER WAS INSERTED AND BELOW (BETWEEN THE GRAY, TEARABLE ELEMENT AND THE TRANSPARENT LATCH). THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NORMAL. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE REPORTED PULL-APART SHEATH WAS THE ONE INCLUDED IN THE KIT. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. MASSIVE BLEEDING OCCURRED, AND IT WAS NECESSARY TO INTERRUPT THE PROCEDURE. THEY REMOVED THE ABOVE-MENTIONED ELEMENT. A NEW PRODUCT WAS OPENED AS REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. NO BLOOD TRANSFUSION WAS ADMINISTERED TO THE PATIENT. THE PATIENT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818018 ↗
• MalfunctionSep 8, 2017Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER STATES AFTER PLACING THE CATHETER, THE DOCTOR TESTED THE BLOOD FLOW WITH THE SYRINGE AND NOTICED THE BLOOD COULDN'T BE DRAWN OUT EASILY. THE CATHETER WAS ADJUSTED BUT THE SITUATION DID NOT IMPROVE. THERE WAS NO HARM OR INTERVENTION REQUIRED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1316-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.