PowerPort M.R.I., ChronoFlex 1806062Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741026966), received between Jul 12, 2018 and May 27, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (2 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 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.

• InjuryMay 27, 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 WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25311608 ↗
• MalfunctionNov 29, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PORT ALLEGEDLY DEVELOPED A CLOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231062 ↗
• MalfunctionAug 30, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY HAD HOLES IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY LEAKED. REPORTEDLY, THE SURGEON HAD TO CUT THE CATHETER MORE THAN ONCE UNTIL THERE WERE NO MORE SIGNS OF (MICRO) HOLES AND THE CATHETER WAS STILL LONG ENOUGH TO NOT HAVE TO OPEN A NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650040 ↗
• MalfunctionAug 29, 2023Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAVE READING OF DEVICE FAILURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643218 ↗
• MalfunctionAug 17, 2023Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT, DURING A PORT PLACEMENT PROCEDURE, THE PORT BODY WAS NOT PATENT AND ALLEGEDLY COULD NOT FLUSH. IT WAS FURTHER REPORTED THAT A NEW PORT BODY WAS CHANGED OUT AND THE PORT WAS ABLE TO BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17567643 ↗
• MalfunctionJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PULLING SENSATION AROUND THE PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16191427 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD BLEEDING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12922352 ↗
• MalfunctionSep 23, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT, THE SHEATH ALLEGEDLY NOT SEPARATED COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517682 ↗
• MalfunctionJan 22, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR PORT PLACEMENT UPON OPENING THE PORT KIT, THE PORT SEPTUM WAS ALLEGEDLY NOTED TO HAVE A SLICE IN IT. ANOTHER PORT KIT WAS OPENED AND PLACED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8266047 ↗
• MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SWELLING AND TENDERNESS AT THE PORT SITE. UPON INJECTION OF CONTRAST, A DISTAL FIBRIN SHEATH AROUND THE TUBING IN THE SVS WAS REPORTEDLY PRESENT AND PRESSURE WAS REQUIRED TO GET FORWARD FLOW. REPORTEDLY AFTER A FEW SECONDS, CONTRAST WAS SEEN AROUND THE PORT RESERVOIR. THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682350 ↗