PowerLine 0700610Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741036590), received between Mar 9, 2017 and Sep 23, 2025 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Loss of or Failure to Bond; Fracture; Material Separation; Device Damaged Prior to Use; Loss of or Failure to Bond; Fracture; Material Separation; Device Damaged Prior to Use

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUFF HAD ALLEGEDLY COME LOOSE FROM THE POWERLINE. REPORTEDLY, DEVICE WAS OPENED, UPON PLACEMENT, AND NOTICED THAT THE CUFF WAS LOOSE AND IT CAME OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23119807 ↗
• MalfunctionDec 13, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE RECEIVED PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922100 ↗
• MalfunctionDec 12, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, RECEIVED PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911281 ↗
• MalfunctionDec 12, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, RECEIVED PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911274 ↗
• MalfunctionDec 12, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, RECEIVED PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911272 ↗
• MalfunctionDec 12, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE RECEIVED PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911270 ↗
• MalfunctionOct 8, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT FIVE MONTHS AND TWENTY-TWO DAYS POST A CHRONIC CATHETER PLACEMENT, THE TUBING WHERE THE RED HUB MEETS THE CATHETER WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT, THE LINE WAS ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20393662 ↗
• MalfunctionJul 15, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE END OF THE CATHETER ALLEGEDLY BROKE OFF UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE REMAINING LINE WAS REMOVED FROM PATIENT. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738185 ↗
• MalfunctionMay 25, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THREE MONTHS AND TWENTY-EIGHT DAYS POST A CHRONIC CATHETER PLACEMENT, THE CLAMP WAS ALLEGEDLY BROKEN ON THE RIGHT SIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398262 ↗
• MalfunctionFeb 21, 2024Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FAILED TO ADHERE. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751817 ↗
• MalfunctionFeb 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE DEVICE WAS ALLEGEDLY REJECTED BY THE BODY. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751628 ↗
• InjuryFeb 21, 2024Fluid/Blood Leak; Loosening of Implant Not Related to Bone-Ingrowth; Fluid/Blood Leak; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ONE MONTH POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD OOZING. REPORTEDLY THE PATIENT DEVELOPED INFECTION. THE PORT REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18745630 ↗
• MalfunctionJan 31, 2024Difficult to Flush; Material Twisted/Bent; Difficult to Flush; Material Twisted/Bent

  IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY DID NOT UNCOIL. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD INFUSION PROBLEM.THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612950 ↗
• MalfunctionDec 20, 2023Failure to Disconnect; Scratched Material; Failure to Disconnect; Scratched Material

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, DURING THE ROUTINE NEEDLE-FREE CONNECTORS CHANGE, CLAMPS WERE NEEDED TO BE PLACED DIRECTLY ON THE COLORED PLASTIC PARTS OF THE CATHETER TO REMOVE THE CONNECTORS, WHICH ALLEGEDLY RESULTED IN A STRIPPING DAMAGE TO THE COLORED PLASTIC PIECES. IT WAS FURTHER REPORTED THAT NEEDLE-FREE CONNECTORS WOULD NOT LOOSEN WITHOUT A CLAMP ON THE NEEDLE-FREE CONNECTORS AND ON THE COLORED PLASTIC PIECE OF THE CATHETER AND TURNING THE CLAMPS IN OPPOSITE DIRECTIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361665 ↗
• MalfunctionDec 14, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY HAD OCCLUSION ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001080 ↗
• MalfunctionJun 21, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKING FROM PLACE WHERE CATHETER MEETS THE HUB ON THE RED LUMEN. IT WAS FURTHER REPORTED THAT A BREAK WAS IDENTIFIED ON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030673 ↗
• MalfunctionJun 3, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST DEVICE PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED AND LEAKED. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928994 ↗
• MalfunctionMay 12, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CHRONIC CATHETER PLACEMENT PROCEDURE, INTRODUCER SHEATH WAS ALLEGEDLY TOO SHORT TO PLACE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812368 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE DEVICE ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587273 ↗
• MalfunctionMar 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD AN EXTERNAL LEAK NEAR CATHETER AND HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479366 ↗
• MalfunctionFeb 17, 2021Obstruction of Flow

  IT WAS REPORTED THAT POST DEVICE PLACEMENT, THE DEVICE ALLEGEDLY WAS REPORTED TO BE OCCLUDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336887 ↗
• MalfunctionFeb 17, 2021Obstruction of Flow

  IT WAS REPORTED SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT, REQUIRE TPA TO USE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336624 ↗
• MalfunctionFeb 17, 2021Obstruction of Flow

  IT WAS REPORTED SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT, TPA HAD TO BE USED WEEKLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336601 ↗
• InjuryFeb 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY BROKE EXTERNALLY. IT WAS FURTHER REPORTED THAT ANOTHER PROCEDURE WITH ANESTHESIA WAS USED TO COMPLETE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11320324 ↗
• MalfunctionFeb 11, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT, TPA HAD TO BE USED FREQUENTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312634 ↗