MAHURKAR 8888123435Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521012516), received between May 11, 2018 and May 11, 2018 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (10 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509228 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON (B)(6), THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN A HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509173 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT , THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509051 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508950 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508691 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN A HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508666 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN A HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508635 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508495 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508462 ↗
• MalfunctionMay 11, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, THE CATHETER¿S VENOUS RETURN WAS ZERO, AND THE CENTRAL LINE WAS OFTEN BLOCKED. IT WAS STATED THAT CONSEQUENCES FOR THE USERS ARE LONGER HOSPITALIZATION, TREATMENT LONGER OR POSTPONED (THEREFORE NOT COMPLETED), MORE CATHETER HANDLING, INCREASED RISK OF INFECTION AND OF VENOUS THROMBOSIS. IT WAS REPORTED THAT THE CATHETER WAS PATENT AND WORKING WELL IN THE RADIOLOGY SUITE, HOWEVER WHEN THE PATIENT SHOWED UP FOR TREATMENT ON MONDAY, THE CATHETER WAS NOT PATENT. THE PATENCY WAS CHECKED PRIOR TO HOOKING IN THE MACHINE AND IT WAS NOT WORKING. THE TREATMENT WAS NEVER STARTED. THE PROCEDURE WAS AN APHERESIS AND THEY WERE UNABLE TO RETRIEVE BLOOD. THE CATHETER WAS NOT MANIPULATED AND DRESSED USING ASEPTIC TECHNIQUE. THERE WAS NO REPORTED BLOOD LOSS AND THE PATIENT WAS JUST GIVEN AN HEPARIN 5000 UNITS (ANTICOAGULANT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508393 ↗

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.