PowerLine 0720515Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741036613), received between Jan 6, 2016 and Jul 14, 2026 — classified as 12 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Fracture; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25814307 ↗
• MalfunctionJun 8, 2026Fluid/Blood Leak

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST THE IMPLANTATION, THE CATHETER WAS ALLEGEDLY LEAKED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423267 ↗
• MalfunctionJun 8, 2026Fluid/Blood Leak

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST THE IMPLANTATION, THE CATHETER WAS ALLEGEDLY LEAKED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423100 ↗
• MalfunctionJun 8, 2026Fluid/Blood Leak

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST THE IMPLANTATION, THE CATHETER WAS ALLEGEDLY LEAKED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423098 ↗
• MalfunctionMay 25, 2026Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING POWERLINE CENTRAL VENOUS CATHETER. POST PROCEDURE, IT WAS REPORTED THAT THE CLAMP SNAPPED OFF COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267576 ↗
• MalfunctionMay 25, 2026Fracture; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING POWERLINE CENTRAL VENOUS CATHETER. POST PROCEDURE, IT WAS REPORTED THAT THE CLAMP SNAPPED OFF COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267574 ↗
• InjuryMay 5, 2026Obstruction of Flow; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST IMPLANTATION, IT WAS REPORTED THAT THE TISSUE CUFF REPORTEDLY CAME OUT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS OBSTRUCTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 25077617 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING POWERLINE CENTRAL VENOUS CATHETER. POST PORT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED INFECTIONS IN THE CENTRAL LINE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24636258 ↗
• InjuryMar 12, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE UTILIZING THE POWERLINE CENTRAL VENOUS CATHETER. 11 DAYS POST PROCEDURE, THE CATHETER HAD A HOLE AND REPORTEDLY LEAKED INTO THE SURROUNDING TISSUE, AND THE PATIENT ALLEGEDLY EXPERIENCED REDNESS. THE LINE WAS SUBSEQUENTLY REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Discomfort; Erythema; Extravasation

  MAUDE report 24580153 ↗
• MalfunctionOct 6, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT A CENTRAL LINE PLACEMENT PROCEDURE USING POWERLINE CV CATHETER. IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE AN APPROXIMATELY 8 CM FRAGMENT, BELIEVED TO BE A CENTRAL LINE GUIDEWIRE, RETAINED IN THE SUPERIOR VENA CAVA (SVC). THE CATHETER LINE WAS REMOVED ON (B)(6) 2025. THE RETAINED FRAGMENT WAS INCIDENTALLY IDENTIFIED ON AN UNRELATED CHEST X-RAY PERFORMED. THE PATIENT DENIED UNDERGOING ANY OTHER PROCEDURES INVOLVING CENTRAL LINE PLACEMENT BETWEEN THE INSERTION AND THE DISCOVERY OF THE FRAGMENT. A REVIEW OF IMAGING TAKEN AFTER THE INITIAL LINE INSERTION DID NOT SHOW THE PRESENCE OF THE GUIDEWIRE FRAGMENT, SUGGESTING IT MAY HAVE BEEN RETAINED DURING THE ORIGINAL 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 23220006 ↗
• InjurySep 10, 2025Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT ON, (B)(6) 2025 POST CENTRAL VENOUS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND TO BE THE SOURCE OF POSITIVE BLOOD CULTURES. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY BROKEN AT THE CUFF. REPORTEDLY, THE TUNNELED CATHETER WAS REMOVED BY INTERVENTIONAL RADIOLOGY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 23013525 ↗
• MalfunctionFeb 3, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291612 ↗
• MalfunctionJan 13, 2025Difficult to Remove; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Remove; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE IN THE LEFT CHEST, IT WAS ALLEGEDLY NOTICED THAT THERE WAS A BENT IN THE TUNNELED CATHETER. IT WAS FURTHER REPORTED THAT GUIDEWIRE WAS ADVANCED TO STRAIGHTEN THE CATHETER CURVE. REPORTEDLY THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO REMOVE FROM LUMEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134617 ↗
• MalfunctionApr 25, 2024Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT NINE MONTHS AND SIX DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A HOLE IN THE TUBING. REPORTEDLY A CRACK WAS ALLEGEDLY NOTICED. IT WAS FURTHER REPORTER THAT THE CATHETER ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184406 ↗
• InjuryOct 9, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED SKIN IRRITATION FROM THE CATHETER DUE TO THE POLYURETHANE MATERIAL. IT WAS FURTHER REPORTED THAT THE LINE WAS REMOVED AND THE PATIENT WAS PLACED ON INTRAVENOUS ANTIBIOTICS. REPORTEDLY, AFTER PLACEMENT ON INTRAVENOUS ANTIBIOTICS, THE PATIENT WAS PLACED WITH A PERIPHERAL LINE MADE WITH SILICONE MATERIAL AND THE PATIENT WAS DISCHARGED WITH IN-HOME INTRAVENOUS ANTIBIOTICS AND DUE TO A COMPROMISED IMMUNE SYSTEM, THE PATIENT COMPLETED TEN DAY AT HOME ANTIBIOTIC REGIME. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. .

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Inflammation/ Irritation

  MAUDE report 17894016 ↗
• MalfunctionJul 24, 2023Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT, THE METALLIC TUNNELER ALLEGEDLY HAD RESIDUAL PLASTIC ON THEM WHEN THE PROTECTIVE COVER IS TAKEN OFF OF THE POINT. IT WAS FURTHER REPORTED THAT THE PLASTIC SAFETY TIP WAS ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377703 ↗
• MalfunctionJul 24, 2023Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT, THE METALLIC TUNNELER ALLEGEDLY HAD RESIDUAL PLASTIC ON THEM WHEN THE PROTECTIVE COVER IS TAKEN OFF OF THE POINT. IT WAS FURTHER REPORTED THAT THE PLASTIC SAFETY TIP WAS ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377626 ↗
• MalfunctionJul 24, 2023Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT, THE METALLIC TUNNELER ALLEGEDLY HAD RESIDUAL PLASTIC ON THEM WHEN THE PROTECTIVE COVER IS TAKEN OFF OF THE POINT. IT WAS FURTHER REPORTED THAT THE PLASTIC SAFETY TIP WAS ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376919 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWO MONTHS AND THREE DAYS POST CATHETER PLACEMENT PROCEDURE, THE LINE ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT FLUID LEAKED FROM LINE. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084580 ↗
• MalfunctionJun 7, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWO WEEKS AND SIX DAYS POST CATHETER PLACEMENT PROCEDURE, THE LINE WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT CATHETER ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078808 ↗
• MalfunctionMar 7, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE TISSUE CUFF ALLEGEDLY CAME OFF WHILE TUNNELING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494033 ↗
• InjuryAug 16, 2022Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT FOUR DAYS POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A DIFFICULTY IN FLUSHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Fever; No Clinical Signs, Symptoms or Conditions; Sepsis

  MAUDE report 15231487 ↗
• InjuryMar 14, 2022Fracture; Material Frayed; Material Separation; Stretched; Fracture; Material Frayed; Material Separation; Stretched

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE OF THE DEVICE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT 1 CM OF THE DEVICE COULD NOT BE RETRIEVED USING ENDOVASCULAR TECHNIQUE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 13755573 ↗
• InjuryFeb 15, 2022Break

  PICC GUIDE WIRE BROKE OFF (SMALL DISTAL TIP) WITH ATTEMPT INSERTION OF PICC RUE; IR PLACEMENT. DIFFICULT PICC PLACEMENT, MOST LIKELY VASOSPASM. NO HARM TO PATIENT, 1 CM COULD NOT BE RETRIEVED USING ENDOVASCULAR TECHNIQUE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542997 ↗
• MalfunctionJun 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY LEAKED FROM THE POINT WHERE THE CATHETER MEETS THE HUB. IT WAS FURTHER REPORTED THAT THE LINE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946891 ↗