PowerLine 0700615Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00801741036606), received between Aug 11, 2016 and Sep 24, 2026 — classified as 2 deaths, 6 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Packaging Problem

  It was reported that medline received damaged PowerLine Central Venous Catheter device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880015 ↗
• MalfunctionApr 30, 2026Fracture

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A POWERLINE CENTRAL VENOUS CATHETER. POST PLACEMENT, IT WAS REPORTED THAT THE CLAMPS WERE REPORTED TO BREAK FREQUENTLY, REQUIRING THE USE OF A CLAMP FROM A DIFFERENT CONNECTOR ON THE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25039416 ↗
• MalfunctionApr 24, 2026Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material

  ON (B)(6) 2025, A PATIENT GETTING PREPARED FOR A CENTRAL LINE PLACEMENT PROCEDURE USING A POWERLINE CENTRAL VENOUS CATHETER. PRIOR TO THE PROCEDURE, THE PLASTIC COVERING ON THE TUNNELLER WAS FOUND TO BE COMPLETELY STUCK AND COULD NOT BE REMOVED. A NEW KIT HAS BEEN OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975879 ↗
• MalfunctionApr 7, 2026Material Integrity Problem

  THE PATIENT UNDERWENT CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND DAMAGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796718 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING POWERLINE CATHETERS. POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE LEAKAGE OBSERVED IN CATHETER. IT WAS FURTHER REPORTED THAT THE LEAKAGE IS AROUND THE CONNECTION BETWEEN THE GROMMET AND THE MAIN CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365202 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING POWERLINE CATHETERS. POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE LEAKAGE OBSERVED IN CATHETER. IT WAS FURTHER REPORTED THAT THE LEAKAGE IS AROUND THE CONNECTION BETWEEN THE GROMMET AND THE MAIN CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364990 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE. POST THE PROCEDURE THE TUBING CONNECTOR TUBE ALLEGEDLY CAME OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910748 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE. POST THE PROCEDURE THE TUBING CONNECTOR TUBE ALLEGEDLY CAME OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910563 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER. ON (B)(6) 2025, POST THE PLACEMENT, IT WAS REPORTED THAT THE TUBING CONNECTOR TUBE ALLEGEDLY CAME OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910560 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE. POST THE PROCEDURE THE TUBING CONNECTOR TUBE ALLEGEDLY CAME OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910555 ↗
• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A POWERLINE AND DURING THE FLUSHING OF PURPLE LUMEN, SALINE IS NOTED TO BE LEAKING RIGHT BACK OUT FROM CATHETER INSERTION SITE. EXIT SITE WAS CLEANSED, REDRESSED AND PATIENT SENT DIRECTLY FROM INFUSION TO IR TO HAVE CATHETER ASSESSED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22220981 ↗
• MalfunctionJan 31, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PACKAGE ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT THE PACKAGING WAS NOT STERILE AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281527 ↗
• MalfunctionOct 9, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CUFF OF THE CATHETER WAS ALLEGEDLY DISLODGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409553 ↗
• InjurySep 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO WEEKS AND FOUR DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY HAD SKIN IRRITATION FROM WET DRESSING, PAIN AT INSERTION SITE, AND ALONG CATHETER. REPORTEDLY, THE INFUSION RATE WAS MODIFIED TO REDUCE THE AMOUNT OF TIME A WET DRESSING REMAINED IN CONTACT WITH SKIN AS WELL AS INCREASED THE HOME HEALTH VISITS TO TWICE A WEEK TO FACILITATE DRESSING CHANGES. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 20219441 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SEVEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211004 ↗
• MalfunctionSep 12, 2024Loss of or Failure to Bond; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SEVEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE CUFF WAS ALLEGEDLY MIGRATED OUT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208800 ↗
• MalfunctionSep 12, 2024Loss of or Failure to Bond; Component Missing; Loss of or Failure to Bond; Component Missing

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY DID NOT HAVE CUFF ON CENTRAL VENOUS CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207923 ↗
• MalfunctionSep 12, 2024Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT TWO WEEKS AND SIX DAYS POST A CHRONIC CATHETER PLACEMENT, THE CUFF WAS ALLEGEDLY MIGRATED OUT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202259 ↗
• MalfunctionSep 9, 2024Component Missing; Device Markings/Labelling Problem; Missing Information; Component Missing; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY RECEIVED WITH NO LABEL AND EXPIRATION DATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170724 ↗
• InjuryJun 4, 2024Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE IN THE LEFT INTRAJUGULAR VEIN, THE GUIDEWIRE WAS ALLEGEDLY FOUND TO BE FRAYED. IT WAS FURTHER REPORTED THE SEPARATED GUIDEWIRE FRAGMENT ALLEGEDLY GOT STUCK INSIDE THE PATIENT. REPORTEDLY, THE GUIDEWIRE FRAGMENT WAS ATTEMPTED FOR REMOVAL THROUGH INTERVENTIONAL RADIOLOGY BUT IT WAS UNABLE TO BE RETRIEVED; THEREFORE, THE RETAINED FRAGMENT HAD TO BE REPOSITIONED INTO A SMALL CHEST WALL VEIN AND THE FRAYED GUIDEWIRE WAS STILL LEFT INSIDE THE PATIENT'S BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19456827 ↗
• MalfunctionJun 3, 2024Device Damaged Prior to Use; Material Integrity Problem; No Apparent Adverse Event; Device Damaged Prior to Use; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD NO PACKAGING OR PRODUCT DAMAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456151 ↗
• MalfunctionJun 3, 2024Device Damaged Prior to Use; Material Integrity Problem; No Apparent Adverse Event; Device Damaged Prior to Use; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456146 ↗
• MalfunctionJan 19, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT EIGHT MONTHS AND TWENTY DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKE UPON REMOVAL. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541058 ↗
• MalfunctionJan 8, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ONE MONTH AND TWENTY-ONE DAYS POST A CHRONIC CATHETER PLACEMENT, THE RED LUMEN ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT FLUID ALLEGEDLY LEAKED RIGHT WHERE THE LUMEN MEETS THE RED PORTION OF THE END OF THE LINE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461897 ↗
• MalfunctionJan 6, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ONE MONTH AND TWENTY-FOUR DAYS POST A CHRONIC CATHETER PLACEMENT, THE RED LUMEN ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT FLUID ALLEGEDLY LEAKED RIGHT WHERE THE LUMEN MEETS THE RED PORTION OF THE END OF THE LINE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461172 ↗