PowerLine 0730615Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741036637), received between Aug 8, 2016 and Apr 3, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Fracture; Material Separation; Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT WAS PREPPED A CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT TWO TRIPLE LUMEN POWERLINES WERE OPENED AND FOUND TO HAVE DAMAGED TUNNELERS. THE END THAT IS INSERTED INTO THE CATHETER WAS BENT, AND WHEN ATTEMPTS WERE MADE TO STRAIGHTEN THEM, THE TUNNELERS SNAPPED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774396 ↗
• MalfunctionApr 1, 2026Fracture; Material Separation; Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT WAS PREPPED A CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT TWO TRIPLE LUMEN POWERLINES WERE OPENED AND FOUND TO HAVE DAMAGED TUNNELERS. THE END THAT IS INSERTED INTO THE CATHETER WAS BENT, AND WHEN ATTEMPTS WERE MADE TO STRAIGHTEN THEM, THE TUNNELERS SNAPPED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754909 ↗
• MalfunctionDec 20, 2023Failure to Disconnect; Scratched Material; Failure to Disconnect; Scratched Material

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT VIA THE LEFT SUBCLAVIAN 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 18361911 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO MONTHS AND THREE DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED WHERE THE LINE CONNECTS TO THE INJECTION PORT. IT WAS FURTHER REPORTED THAT THE LINE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618303 ↗
• InjuryNov 16, 2022Migration; Migration

  IT WAS REPORTED THAT TWO DAYS POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE LINE ALLEGEDLY MIGRATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 15803651 ↗
• MalfunctionNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. REPORTEDLY, THERE IS NO INFORMATION REGARDING THE TREATMENT OF THE INFECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15750452 ↗
• MalfunctionNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. REPORTEDLY, THERE IS NO INFORMATION REGARDING THE TREATMENT OF THE INFECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15750369 ↗
• InjuryOct 25, 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 NINETEEN DAYS POST INDEX PROCEDURE COMPLETION USING A CHRONIC CATHETER PLACEMENT, THE SUBJECT DEVELOPED ADVERSE EVENT OF BACTEREMIA. IT WAS FURTHER REPORTED THAT APPROXIMATELY THREE MONTHS AND TWENTY 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: Bacterial Infection

  MAUDE report 15664891 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY FOUR MONTHS AND TWENTY-SEVEN DAYS POST CATHETER PLACEMENT, THE SUBJECT DEVELOPED ADVERSE EVENT OF CANDIDEMIA. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fungal Infection

  MAUDE report 15500180 ↗
• MalfunctionDec 31, 2021Loss of or Failure to Bond; Fluid/Blood Leak; Fracture; Material Separation; Air/Gas in Device; Loss of or Failure to Bond; Fluid/Blood Leak; Fracture; Material Separation; Air/Gas in Device

  IT WAS REPORTED THAT FOUR MONTHS POST CHRONIC CATHETER PLACEMENT, A PIN HOLE SIZED LEAK WAS ALLEGEDLY NOTED ON THE LINES. IT WAS FURTHER REPORTED THAT AIR WAS NOTED TO ENTER WITH INFUSION. THE LINE WAS REPORTED TO BE CLAMPED OFF AND COVERED WITH TEGADERM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13123722 ↗
• MalfunctionDec 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT SOME TIME POST CHRONIC CATHETER PLACEMENT, THE CATHETER CUFF WAS ALLEGEDLY MISSING UPON REMOVAL FORM PATIENT BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932020 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 12431490 ↗
• MalfunctionSep 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE DEVICE ALLEGEDLY FRACTURED AT THE CLAMPING SITES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405248 ↗
• MalfunctionDec 29, 2020Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CUFF ALLEGEDLY FELL OFF FROM THE CATHETER. IT WAS FURTHER REPORTED THAT THE CUFF WAS REMOVED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085678 ↗
• MalfunctionApr 14, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0730615 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960426 ↗
• MalfunctionJun 16, 2017Device Operates Differently Than Expected

  NURSE REPORTED TO MS&S, THAT THEY TYPICALLY USE THE DUAL POWERLINE AND AS PART OF THEIR PROTOCOL THEY ADMINISTER A DRUG CALLED PROGRAF (TACROLIMUS) IV AND THEN DRAW DRUG LEVELS OVER A SERIES OF WEEKS FROM A DIFFERENT LUMEN AND HAVE NOT HAD ANY ISSUES WITH ¿SKEWED VALUES¿. THE FACILITY RECENTLY TRIED THE TRIPLE LUMEN POWERLINE WITH TWO PATIENTS AND THEY HAD EXTREMELY ELEVATED DRUG LEVELS WITH BLOOD DRAW THROUGH THE LINE EVEN THREE WEEKS AFTER THE INFUSION. THE NURSE STATED THAT IN ONE CASE THE DRUG LEVEL AS 30, WHICH IS EXTREMELY HIGH AND WHEN THEY DID A PERIPHERAL BLOOD DRAW IT WAS ONLY 2. THE NURSE WAS WONDERING IF THE DRUG IS LEECHING THROUGH THE POLYURETHANE MATERIAL DUE TO THE WALL THICKNESS OR ALCOHOL CONTENT. IT ALSO HAS CASTOR OIL IN THE DRUG WHICH COULD LEAD TO IT COATING THE TUBING; HOWEVER, THEY ARE DRAWING BLOOD FROM A DIFFERENT LUMEN NOT THE INFUSION LUMEN. ANOTHER POSSIBILITY IS THAT A SMALL FIBRIN TAIL OR SHEATH COULD BE DIRECTING THE DRUG FROM ONE LUMEN INTO THE OTHER SINCE THEY ARE VERY CLOSE TOGETHER. THE FACILITY HAS NOT EXPERIENCED THIS ISSUE WITH THE DUAL LUMEN POWERLINES. NO REPORTED PATIENT HARM. THIS FILE ADDRESSES PATIENT TWO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6647699 ↗
• MalfunctionJun 16, 2017Unexpected Therapeutic Results; High Test Results

  NURSE REPORTED TO MS&S, THAT THEY TYPICALLY USE THE DUAL POWERLINE AND AS PART OF THEIR PROTOCOL THEY ADMINISTER A DRUG CALLED PROGRAF (TACROLIMUS) IV AND THEN DRAW DRUG LEVELS OVER A SERIES OF WEEKS FROM A DIFFERENT LUMEN AND HAVE NOT HAD ANY ISSUES WITH ¿SKEWED VALUES¿. THE FACILITY RECENTLY TRIED THE TRIPLE LUMEN POWERLINE WITH TWO PATIENTS AND THEY HAD EXTREMELY ELEVATED DRUG LEVELS WITH BLOOD DRAW THROUGH THE LINE EVEN THREE WEEKS AFTER THE INFUSION. THE NURSE STATED THAT IN ONE CASE THE DRUG LEVEL AS 30, WHICH IS EXTREMELY HIGH AND WHEN THEY DID A PERIPHERAL BLOOD DRAW IT WAS ONLY 2. THE NURSE WAS WONDERING IF THE DRUG IS LEECHING THROUGH THE POLYURETHANE MATERIAL DUE TO THE WALL THICKNESS OR ALCOHOL CONTENT. IT ALSO HAS CASTOR OIL IN THE DRUG WHICH COULD LEAD TO IT COATING THE TUBING; HOWEVER, THEY ARE DRAWING BLOOD FROM A DIFFERENT LUMEN NOT THE INFUSION LUMEN. ANOTHER POSSIBILITY IS THAT A SMALL FIBRIN TAIL OR SHEATH COULD BE DIRECTING THE DRUG FROM ONE LUMEN INTO THE OTHER SINCE THEY ARE VERY CLOSE TOGETHER. THE FACILITY HAS NOT EXPERIENCED THIS ISSUE WITH THE DUAL LUMEN POWERLINES. NO REPORTED PATIENT HARM. THIS FILE ADDRESSES PATIENT ONE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 6647581 ↗
• MalfunctionAug 8, 2016Leak/Splash

  IT WAS REPORTED THAT A POWERLINE WAS INSERTED ON (B)(6) 2016 BUT A HOLE WAS NOTICED AT A FOLLOW-UP. THE RADIOLOGY DEPARTMENT WAS INFORMED AND THE LINE WAS REMOVED ON (B)(6) 2016. THE LEAK WAS IDENTIFIED A COUPLE OF CENTIMETERS ABOVE THE CUFF IN THE SUBCUTANEOUS TUNNEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5855216 ↗