PowerPort, ChronoFlex 1708050Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741026591), received between Jul 23, 2019 and Feb 3, 2026 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24246499 ↗
• DeathNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH PULMONARY EMBOLISM. THE PATIENT LATER PASSED AWAY; HOWEVER, THE CAUSE OF DEATH WAS NOT DISCLOSED.

  Patient problems: Pulmonary Embolism

  MAUDE report 23447868 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23298601 ↗
• InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION, FIBRIN SHEATH FORMATION OF CATH TIP AND STENOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Stenosis; Unspecified Infection

  MAUDE report 22522330 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT TI ISP. SOMETIME POST A PORT PLACEMENT PROCEDURE THE PATIENT ALLEGEDLY EXPERIENCED A CIRCULAR RASH AT THE PORT SITE.

  Patient problems: Rash

  MAUDE report 22103024 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 21261699 ↗
• MalfunctionAug 29, 2022Difficult to Insert; Component Misassembled; Physical Resistance/Sticking; Difficult to Insert; Component Misassembled; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE BREAKAWAY SHEATH AND INTRODUCER NEEDLE WERE ALLEGEDLY FOUND TO BE IN WRONG SIZE. IT WAS FURTHER REPORTED THAT, THE GUIDEWIRE WAS ALLEGEDLY COULD NOT BE FIT TO THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15308944 ↗
• InjurySep 25, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT FIVE MONTHS POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD DIFFICULTY DRAWING BLOOD FROM THE PORT. IT WAS FURTHER REPORTED THAT RADIOLOGIST STATED THAT THE PORT IS WORKING PROPERLY AND THE TIP OF THE CATHETER WAS IN THE VENA CAVA AND THE PATIENT ALLEGEDLY FELT PAIN. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 10584896 ↗
• MalfunctionApr 14, 2020Break; Fracture; Break; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1708050 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A FRACTURE AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. THEREFORE, THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9960523 ↗
• MalfunctionJul 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1708050 IMPLANTABLE PORT ALLEGEDLY LEAKED. ONE OF THE DEVICES WAS UNABLE TO BE USED AND WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE AGE OF THE PATIENTS RANGED FROM 2 YEARS TO 65 YEARS. BOTH PATIENTS WERE FEMALE AND THE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818892 ↗