PowerPort M.R.I., ChronoFlex 1808070Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741027079), received between Nov 30, 2023 and Sep 29, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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.

• InjurySep 29, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50928108 ↗
• InjuryMay 25, 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 25271091 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23521962 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT HAD ALLEGEDLY OBSTRUCTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048332 ↗
• InjuryJul 24, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22587057 ↗
• InjuryMay 26, 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 WAS ALLEGEDLY DIAGNOSED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22083401 ↗
• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, PATIENT UNDERWENT BARD MRI POWERPORT IMPLANTABLE PORT PLACEMENT PROCEDURE. ABOUT SOMETIME AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21783616 ↗
• InjurySep 22, 2024Adverse 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 HAD ALLEGEDLY DEVELOPED AN INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 20275858 ↗
• InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO MONTHS AND EIGHTEEN DAYS POST A PORT PLACEMENT IN THE RIGHT ATRIAL SUPERIOR VENA CAVA JUNCTION VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AND THE BLOOD CULTURE TEST RESULTED POSITIVE FOR STAPHYLOCOCCUS AUREUS BACTERIAL INFECTION AS A RESULT OF THE DEFECTIVE INFECTED PORT. REPORTEDLY, THE DEFECTIVE INFECTED PORT AND CATHETER WERE REMOVED FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 19736800 ↗
• MalfunctionNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED NECK DISCOMFORT. IT WAS FURTHER REPORTED THAT A LITTLE BRUISE WAS FORMED IN THE AREA WHERE THE NEEDLE WAS INSERTED IN THE SKIN. HOWEVER, THERE IS NO INFORMATION ON ANY INTERVENTION OR MEDICATIONS PROVIDED TO TREAT BRUISE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239238 ↗