Hickman Hemodialysis/Apheresis Catheter 0600660Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741037504), received between Dec 21, 2015 and Aug 1, 2022 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Difficult to Flush; Fracture; Difficult to Flush; Fracture

  IT WAS REPORTED THAT DURING PREPARATION OF DIALYSIS CATHETER IMPLANT PROCEDURE, THE PUNCTURE NEEDLE ALLEGEDLY CANNOT RINSE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138224 ↗
• InjuryAug 15, 2021Material Puncture/Hole; Pressure Problem; Material Puncture/Hole; Pressure Problem

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD A PRESSURE PROBLEM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12322323 ↗
• MalfunctionDec 11, 2020Material Puncture/Hole; Suction Problem; Material Puncture/Hole; Suction Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PULL BACK THE BLOOD ON HICKMAN CATHETER, BLOOD WAS NOT RETURNED. IT WAS FURTHER REPORTED THAT A HOLE WAS OPENED NEAR A SEAM WHILE ATTEMPTED TO FLUSH THE DEVICE AT NORMAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10990770 ↗
• MalfunctionOct 17, 2019Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600660 DIALYSIS CATHETER ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT AND WAS DISLODGED/DISLOCATED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204281 ↗
• MalfunctionJul 23, 2019Fracture; Defective Component; Fracture; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 600660 LONG TERM HEMODIALYSIS CATHETER ALLEGEDLY HAD DEFECTIVE COMPONENTS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITHOUT CONSEQUENCE. THE PATIENT AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817716 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED APPROXIMATELY TWO WEEKS POST PLACEMENT THAT THE DIALYSIS CATHETER ALLEGEDLY DISLODGED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOLLOWING REMOVAL AND REPLACEMENT OF THE DEVICE.

  Patient problems: Injury

  MAUDE report 8604946 ↗
• MalfunctionOct 13, 2017Hole In Material

  IT WAS REPORTED THAT CATHETER WAS IMPLANTED ON (B)(6) 2017. PATIENT ARRIVED TO START THE HEMODIALYSIS SESSION AND IN THE MOMENT OF INSTALLATION IT WAS OBSERVED AN "OPENING" (HOLE) IN THE CATHETER'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949435 ↗
• MalfunctionAug 10, 2016Leak/Splash

  FACILITY CONTACT REPORTED THAT ON (B)(6) 2016, STEM CELL INFUSION WAS STARTED AND IT WAS NOTED THAT THE HICKMAN CATHETER LEAKED AT THE INSERTION SITE. A .60 ML OF THE 100ML SYRINGE HAD ALREADY BEEN INFUSED WHEN LEAKAGE NOTED. THE REPORTED LEAKING WAS NOTED ON (B)(6) 2016 WHILE CHEMOTHERAPY WAS INFUSING. PATIENT HAD BEEN SENT TO INTERVENTIONAL RADIOLOGY WHERE LINE WAS SAID TO BE OK AND NO LEAKING NOTED. THE HICKMAN WAS REMOVED FROM PATIENT ON (B)(6) 2016. THE PATIENT DID NOT RECEIVE FULL COMPLIMENT OF STEM CELLS. ON 07/20/2016 - ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT STATING THAT THE LEAKING WAS AROUND THE INSERTION SITE AS FAR AS THEY COULD TELL. WHEN THE LEAK WAS FIRST NOTICED, THE PATIENT'S DRESSING WAS WET AND HAD LEAKED ONTO HER GOWN. THE CHEMO WAS STOPPED. THE PATIENT WAS SENT TO IR . NO LEAK WAS FOUND BUT A SHEATH WAS PRESENT; THE CATHETER WAS REPORTED TO BE GOOD FOR USE. THE NEXT DAY, THE COMPLAINANT CHECKED THE CATHETER AND BEGAN INFUSING STEM CELLS AND NOTICED LEAKING AROUND THE CATHETER SITE. THE CATHETER WAS REMOVED AND PLACED IN A SEALED BAG. NO TESTS WERE DONE TO IT TO DETERMINE IF THE LEAK WAS ON THE EXTERNAL PORTION OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5867213 ↗
• MalfunctionDec 21, 2015Physical Property Issue

  AS REPORTED TO IBC: WHEN THE PHYSICIAN RETRACTED THE CATHETER FROM PATIENT, HE ALLEGEDLY FOUND THAT THE CATHETER BECAME BRITTLE. THE BRITTLE POSITION WAS REPORTEDLY OUTSIDE THE PATIENT BUT NEAR PATIENT'S SKIN. ON (B)(6) 2015 - SAMPLE EVALUATION SHOWS BOTH LUMENS OF THE CATHETER WERE BREACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5315172 ↗