Hickman 0601760Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741036484), received between Sep 21, 2021 and Jul 2, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 reports).

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 4, 2023Open, Classified

   Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

   Z-1051-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionJul 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2025 A PATIENT UNDERWENT THE PORT PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE REPAIR KITS ALLEGEDLY FOUND ADHESIVE CONCERN. IT WAS FURTHER REPORTED THAT AFTER COMPLETING THE REPAIR AND ALLOWING ADEQUATE DRY TIME, THE ADHESIVE DOES NOT HOLD THE REPAIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381549 ↗
• MalfunctionJul 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2025, A PATIENT UNDERWENT THE PORT PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE REPAIR KITS ALLEGEDLY FOUND ADHESIVE CONCERN. IT WAS FURTHER REPORTED THAT AFTER COMPLETING THE REPAIR AND ALLOWING ADEQUATE DRY TIME, THE ADHESIVE DOES NOT HOLD THE REPAIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381545 ↗
• MalfunctionJul 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2025 A PATIENT UNDERWENT THE PORT PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE REPAIR KITS ALLEGEDLY FOUND ADHESIVE CONCERN. IT WAS FURTHER REPORTED THAT AFTER COMPLETING THE REPAIR AND ALLOWING ADEQUATE DRY TIME, THE ADHESIVE DOES NOT HOLD THE REPAIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381491 ↗
• MalfunctionMay 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER PEDIATRIC. SOMETIME POST PLACEMENT, IT WAS NOTED THAT THE REPAIR KIT ADHESIVE WAS NOT HOLDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085547 ↗
• MalfunctionMay 27, 2025Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER PEDIATRIC. SOMETIME POST PLACEMENT, IT WAS NOTED THAT THE REPAIR KIT ADHESIVE WAS NOT HOLDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085539 ↗
• MalfunctionMay 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER PEDIATRIC. SOMETIME POST PLACEMENT, IT WAS NOTED THAT THE REPAIR KIT ADHESIVE WAS NOT HOLDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085412 ↗
• MalfunctionMar 3, 2025Fracture; Material Separation; Device Damaged Prior to Use; Material Integrity Problem; Fracture; Material Separation; Device Damaged Prior to Use; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER REPAIR KIT PROCEDURE, THE DEVICE WAS ALLEGEDLY DAMAGED WHEN OPENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503282 ↗
• MalfunctionAug 23, 2024Fluid/Blood Leak; Fitting Problem; Defective Component; Material Deformation; Air/Gas in Device; Fluid/Blood Leak; Fitting Problem; Defective Component; Material Deformation; Air/Gas in Device

  IT WAS REPORTED THAT DURING CHRONIC CATHETER REPAIR PROCEDURE, THERE IS A CLEAR PIECE PRESENT AROUND THE METAL LUMEN STENTS THAT ALLEGEDLY WOULD NOT CONNECT TO THE PATIENT'S LINE. IT WAS FURTHER REPORTED THAT WHEN TRIED TO CONNECT AND FLUSH AND DRAW THE PIECES WOULD NOT FIT TOGETHER AND WOULD LEAK BLOODY SALINE AND DRAW IN AIR BUBBLES. REPORTEDLY, THE REPAIR KIT WAS ALLEGEDLY DEFORMED. THE REPAIR KIT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047650 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CATHETER REPAIR PROCEDURE PROCEDURE, THE LUMEN ALLEGEDLY DETACHED FROM THE REPAIR SITE. REPORTEDLY, THE HARD PIECE WAS FELT IN THE LUMEN NEARER TO THE BIFURCATION. HOWEVER, THE HARD PIECE WAS CUT OPENED AND IT SEEMS LIKE THE METAL CONNECTOR WAS ALLEGEDLY DETACHED AND MIGRATED TOWARDS THE BIFURCATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137745 ↗
• MalfunctionMar 30, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A CATHETER REPAIR PROCEDURE, THE DEVICE WAS ALLEGEDLY MANUFACTURED IN A WAY TO PREVENT THE TWO ENDS OF THE DEVICE FROM BEING WELL APPROXIMATED WHICH RESULTED GAP BETWEEN THE TWO ENDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13947754 ↗
• MalfunctionJan 10, 2022Backflow; Loss of or Failure to Bond; Reflux within Device; Detachment of Device or Device Component; Backflow; Loss of or Failure to Bond; Reflux within Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THREE HOURS POST CATHETER REPAIR PROCEDURE, THE JOINING CONNECTOR OF THE REPAIR KIT WAS ALLEGEDLY NOTED TO BE DETACHED FROM THE REPAIR SITE AND BLOOD BACKFLOW WAS NOTED. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED ANEMIA. THE CATHETER WAS REMOVED AND PATIENT REPORTED TO BE STABLE AFTER ANEMIA RECOVERY.

  Patient problems: Anemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204064 ↗
• MalfunctionSep 21, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST CATHETER PLACEMENT, THE CATHETER HUB WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505209 ↗