Hickman 0600160Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741051722), received between Jun 29, 2017 and May 8, 2023 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF ALLEGEDLY SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888857 ↗
• MalfunctionMay 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF WAS ALLEGEDLY SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887667 ↗
• MalfunctionMar 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596946 ↗
• MalfunctionOct 11, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CW 12/28 IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF OF THE DEVICE WAS ALLEGEDLY SEPARATED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579022 ↗
• MalfunctionApr 27, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CUFF WAS ALLEGEDLY SEPARATED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218262 ↗
• InjuryAug 13, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED TO PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 12317773 ↗
• InjuryAug 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED TO PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 12317563 ↗
• MalfunctionMar 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CUFF ALLEGEDLY GOT SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580630 ↗
• MalfunctionJan 19, 2021Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE CUFF IS SEPARATED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT THE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11192131 ↗
• MalfunctionOct 28, 2020Loss of or Failure to Bond; Material Split, Cut or Torn; Loss of or Failure to Bond; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600160 CHRONIC CATHETER ALLEGEDLY EXPERIENCED CUFF DETACHMENT. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWO MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750222 ↗
• MalfunctionJan 15, 2020Defective Component; Defective Component

  THIS REPORT SUMMARIZES FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600160 CHRONIC CATHETER ALLEGEDLY EXPERIENCED DEFECTIVE COMPONENTS. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL FOUR EVENTS HAD NO REPORTED PATIENT INJURY AND ONE EVENT HAD NO REPORTED PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592298 ↗
• MalfunctionJun 29, 2017Detachment Of Device Component; Component Falling

  IT WAS REPORTED THE CUFF FELL OFF. ADDITIONAL INFORMATION: FACILITY REPORTS THE CUFF FELL OFF THE CATHETER DURING CATHETER INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6679178 ↗