PowerLine 0700515Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00801741036583), received between Jan 27, 2016 and Sep 18, 2026 — classified as 15 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Nonstandard Device

  On (b)(6) 2026, a patient was schedule to undergo a chronic catheter placement procedure by using the Powerline Catheter. Prior to the procedure, it was reported that the PowerLine catheter was labeled as containing a cuff however, upon inspection, no cuff was present on the catheter. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820942 ↗
• MalfunctionJun 18, 2026Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON RECEIPT OF PURCHASE ORDER. THE EXTERNAL SHIPPING BOX WAS OBSERVED TO BE IN GOOD CONDITION WITH NO VISIBLE DAMAGE; HOWEVER, THE PRODUCT INSIDE WAS FOUND TO BE DAMAGED, SPECIFICALLY NOTED TO HAVE A HOLE, RENDERING IT CONTAMINATED, DIRTY AND UNSUITABLE FOR USE. IN ADDITION, A QUANTITY DISCREPANCY WAS IDENTIFIED, AS ONLY ONE UNIT WAS RECEIVED INSTEAD OF THE EXPECTED ONE CASE OF FIVE UNITS, AS INDICATED IN THE PACKING LIST DOCUMENTATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547027 ↗
• MalfunctionFeb 16, 2026Fracture

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER. POST PROCEDURE ON (B)(6) 2025, THE CATHETER GOT FRACTURED DURING REMOVAL. THE ISSUE WAS IDENTIFIED BY THE HEALTHCARE PROVIDER AT THE TIME OF CATHETER EXTRACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342145 ↗
• MalfunctionDec 3, 2025Loss of or Failure to Bond; Component Missing; Loss of or Failure to Bond; Component Missing

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE BY USING POWERLINE 5F SINGLE-LUMEN POLYURETHANE CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE VALVE PIECE WAS ALLEGEDLY MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702897 ↗
• MalfunctionNov 18, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER. DURING THE PROCEDURE, THE PIECE OF THE TUNNELER BROKE OFF WHILE ATTEMPTING TO REMOVE THE PROTECTIVE COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579373 ↗
• InjuryNov 3, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A 46-YEAR-OLD FEMALE PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING POWER LINE CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, THE LINE WAS ALLEGEDLY FOUND LEAKING AROUND WHERE THE TUBING GOES INTO THE PURPLE HUB ON THE END. IT WAS FURTHER REPORTED THAT THE PATIENT WHO ALLEGEDLY EXPERIENCED SIGHT AND APPEARED TO BE POTENTIALLY INFECTED. REPORTEDLY, THE DEVICE WAS REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 23447548 ↗
• MalfunctionSep 17, 2025Packaging Problem; Missing Information; Packaging Problem; Missing Information

  ON (B)(6) 2025 A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT FOR UNKNOWN MEDICAL CONDITION. PRIOR TO THE PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY FOUND DAMAGED AND THE STICKERS FOR SCANNING ARE MISSING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070606 ↗
• MalfunctionSep 2, 2025Loss of or Failure to Bond; Fracture; Material Separation; Migration; Loss of or Failure to Bond; Fracture; Material Separation; Migration

  ON (B)(6) 2025 A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CATHETER. ON (B)(6) 2025, THE CUFF WAS RETAINED DURING PICC REMOVAL PROCEDURE. 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 22929981 ↗
• MalfunctionMay 12, 2025Loss of or Failure to Bond; Expulsion; Loss of or Failure to Bond; Expulsion

  ON (B)(6) 2025, POWERLINE WAS PLACED. A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE BY USING THE POWERLINE CATHETER. POST A CHRONIC CATHETER PROCEDURE, IT WAS FURTHER REPORTED THAT THE CUSS IS STARTING TO COME OUT OF THE INCISION SITE. FURTHER, THIS IS THE THIRD POWERLINE THAT HAS BEEN PLACED AND HAS THE SAME RESULTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001005 ↗
• MalfunctionApr 21, 2025Loss of or Failure to Bond; Component Missing; Loss of or Failure to Bond; Component Missing

  IT WAS REPORTED THAT DURING PREPARATION OF A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY DID NOT MAKE IT INTO THE PATIENT BECAUSE THERE WAS NO CUFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871354 ↗
• InjuryFeb 13, 2025Entrapment of Device; Fracture; Material Separation; Migration; Entrapment of Device; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE TIP OF THE WIRE WAS SHEARD OFF AND ALLEGEDLY WENT INTO SOFT TISSUE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 21372108 ↗
• MalfunctionJan 2, 2025Loss of or Failure to Bond; Material Separation; Component Missing; Loss of or Failure to Bond; Material Separation; Component Missing

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LINE WAS ALLEGEDLY RECEIVED WITH NO CUFF ATTACHED TO THE CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057923 ↗
• MalfunctionDec 31, 2024Loss of or Failure to Bond; Fracture; Material Separation; Loss of or Failure to Bond; Fracture; Material Separation

  IT WAS REPORTED THAT DURING THE PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF ALLEGEDLY FALLS OFF AND ALSO CUFF ALLEGEDLY BROKEN AND SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046485 ↗
• MalfunctionDec 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF WAS NOT STATIONARY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21009973 ↗
• MalfunctionJun 19, 2024Loss of or Failure to Bond; Device Markings/Labelling Problem; Loss of or Failure to Bond; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, RECEIVED A BOX OF POWERLINES AND EXTERNAL PACKAGING WAS ALLEGEDLY FOUND TO BE DAMAGED. IT WAS FURTHER REPORTED THAT THE LABELS ON THE OUTSIDE OF THE PACKAGING WERE ALLEGEDLY NOT STICKING AND IT EASILY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571422 ↗
• MalfunctionJun 19, 2024Loss of or Failure to Bond; Device Markings/Labelling Problem; Loss of or Failure to Bond; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABELS ON THE OUTSIDE OF THE PACKAGING WERE NOT ALLEGEDLY STICKING AND IT EASILY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567840 ↗
• MalfunctionJun 19, 2024Loss of or Failure to Bond; Device Markings/Labelling Problem; Loss of or Failure to Bond; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABELS ON THE OUTSIDE OF THE PACKAGING WERE NOT ALLEGEDLY STICKING AND IT EASILY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567839 ↗
• MalfunctionJun 19, 2024Loss of or Failure to Bond; Device Markings/Labelling Problem; Loss of or Failure to Bond; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABELS ON THE OUTSIDE OF THE PACKAGING WERE ALLEGEDLY NOT STICKING AND IT EASILY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567837 ↗
• MalfunctionJun 19, 2024Loss of or Failure to Bond; Device Markings/Labelling Problem; Loss of or Failure to Bond; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABELS ON THE OUTSIDE OF THE PACKAGING WERE NOT ALLEGEDLY STICKING AND IT EASILY FELL OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567835 ↗
• MalfunctionMay 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST A CHRONIC CATHETER PLACEMENT, THE CLAMP WAS ALLEGEDLY BROKEN. REPORTEDLY, THE CLAMP WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379048 ↗
• InjuryMay 15, 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 SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CUFF OF THE CATHETER ALLEGEDLY MIGRATED OUTSIDE OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 19317801 ↗
• MalfunctionApr 11, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT ONE MONTH AND TWENTY-THREE DAYS POST A CHRONIC CATHETER PLACEMENT, THE CUFF ALLEGEDLY DETACHED AND REMAINED INSIDE THE PATIENT'S BODY DURING REMOVAL. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO REMOVE THE CUFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086360 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. IT WAS FURTHER REPORTED THAT ANTIBIOTICS WAS GIVEN FOR INFECTION. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 18541505 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A LEAK AND WAS FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541482 ↗
• MalfunctionDec 20, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY DID NOT STAY CONNECTED TO THE TUBING. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366354 ↗