PowerHickman 0805910Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741036682), received between Jun 16, 2016 and Sep 17, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Connection Problem

  On (b)(6) 2026, a patient underwent Central venous catheter placement procedure using PowerHickman Central Venous Catheter. During device preparation, it was noted that the tunneler would not remain securely attached to the catheter and repeatedly detached from it. The procedure was completed using another device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802830 ↗
• MalfunctionApr 3, 2026Material Integrity Problem

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE WITH POWERHICKMAN CENTRAL VENOUS CATHETER. SOMETIMES LATER, THE IMPLANTED CATHETER WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775969 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole

  A PATIENT UNDERWENT A POWER HICKMAN CATHETER PLACEMENT PROCEDURE. POST PROCEDURE, IT WAS REPORTED THAT ONE OF THE HUBS OF THE POWER HICKMAN CATHETER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243396 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak; Material Puncture/Hole

  A PATIENT UNDERWENT CATHETER PLACEMENT PROCEDURE USING THE POWERHICKMAN. DURING THE PROCEDURE, IT WAS REPORTED THAT CATHETER HAD MALL PERFORATION LOCATED JUST ABOVE THE HUB, CAUSING LEAKAGE. THE CALLER INDICATED THAT THE SURGEON SUSPECTS THE PERFORATION MAY HAVE OCCURRED DUE TO FLUSHING WHILE THE CATHETER WAS CLAMPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231485 ↗
• MalfunctionApr 16, 2025Difficult to Flush; Reflux within Device; Suction Problem; Difficult to Flush; Reflux within Device; Suction Problem

  IT WAS REPORTED THAT APPROXIMATELY ELEVEN DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD KINKED UPON REMOVAL. IT WAS FURTHER REPORTED THAT CATHETER HAD ISSUES IN BOTH INFUSION AND ASPIRATION. REPORTEDLY THE INFUSION WAS PUMPED THROUGH ONE PORT AND WERE BACKFLOWING THROUGH THE OTHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846216 ↗
• MalfunctionMar 13, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PEEL AWAY SHEATH ALLEGEDLY DID NOT PEEL PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892137 ↗
• MalfunctionNov 13, 2023Fracture; Device Damaged Prior to Use; Difficult or Delayed Separation; Fracture; Device Damaged Prior to Use; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PEEL AWAY SHEATH WAS ALLEGEDLY FAULTY WITHIN THE KIT. IT WAS FURTHER REPORTED THAT A PORTION OF THE VALVE AND THE VALVE FRAME ALLEGEDLY GOT STUCK AND NEEDED TO BE CUT AWAY FROM THE CATHETER. REPORTEDLY, THE FRAME WAS ALLEGEDLY BROKEN AWAY FROM THE VALVE AND THE VALVE FAILED TO SEPARATE ON ITS OWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117844 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY THREE MONTHS AND FOURTEEN DAYS POST INDEX PROCEDURE COMPLETION USING A CHRONIC CATHETER PLACEMENT, THE SUBJECT DEVELOPED ADVERSE EVENT OF RIGHT INTERNAL JUGULAR THROMBUS AT CATHETER SITE WHICH REQUIRED ADDITIONAL MEDICAL INTERVENTION. IT WAS FURTHER REPORTED THAT APPROXIMATELY FIFTEEN DAYS POST INDEX PROCEDURE, EVENT REQUIRED RE-INTERVENTION AND THE CATHETER WAS REMOVED, AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15795568 ↗
• MalfunctionSep 1, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, ONE LUMEN OF THE CATHETER WAS ALLEGEDLY FOUND TO BE DISCOLORED. IT FURTHER REPORTED THAT THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408115 ↗
• MalfunctionOct 27, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A CATHETER PLACEMENT, THE DEVICE PACKAGE ALLEGEDLY TORN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740683 ↗
• MalfunctionOct 27, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A CATHETER PLACEMENT, THE DEVICE PACKAGE ALLEGEDLY TORN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740512 ↗
• MalfunctionOct 27, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A CATHETER PLACEMENT, THE DEVICE PACKAGE ALLEGEDLY TORN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740407 ↗
• MalfunctionOct 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL 0805910 CHRONIC CATHETER ALLEGEDLY EXPERIENCED CATHETER DISLODGEMENT. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE TWO EVENTS, BOTH INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR BOTH PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209552 ↗
• InjuryOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY EIGHT WEEKS POST CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND DISLODGED AND THERE WERE NO EXIT SUTURES; HOWEVER, MEPILEX WITH BORDER AND STATLOCK WERE IN PLACE. IT WAS FURTHER REPORTED THAT SIGNIFICANT BLOOD LOSS WAS OBSERVED. REPORTEDLY, PERIPHERALLY INSERTED CENTRAL CATHETER WAS INSERTED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Blood Loss

  MAUDE report 9204056 ↗
• MalfunctionAug 3, 2017Break; Out-Of-Box Failure

  PER SALES REP, THE FACILITY REPORTED THAT UPON OPENING THE PACKAGE, ONE HALF OF THE VALVE ASSEMBLY WAS FOUND BROKEN WITHIN THE KIT. A SECOND DEVICE/PACKAGE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6765752 ↗
• MalfunctionJun 16, 2016Device Packaging Compromised

  ON 5/25/16 - IT WAS REPORTED BY COMPLAINANT THAT THE HICKMAN PACKAGING HAS A SLIT AND A MARK ON THE OUTSIDE OF THE PACKAGE. THEY ALSO REPORTED THAT THERE WAS "SWEAT" IN THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5730205 ↗