PowerPort M.R.I., ChronoFlex 1806061Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741026959), received between Nov 27, 2018 and Jul 1, 2026 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 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 25674734 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24065468 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TEN MONTHS AND FOURTEEN DAYS POST PORT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN FOR REPEATED VEIN ACCESS, THE PATIENT DEVELOPED PAIN, FEVER OVER PORT SITE AND DIAGNOSED WITH BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Fever; Pain

  MAUDE report 22791569 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT ELEVEN MONTHS FIVE DAYS POST PORT PLACEMENT PROCEDURE FOR REPEATED VEIN ACCESS, THE PATIENT DEVELOPED PAIN, ERYTHEMA OVER PORT SITE AND DIAGNOSED WITH INFECTION CONFIRMED BY BLOOD CULTURES. ON REMOVAL, PATIENT DIAGNOSED WITH THROMBOSIS AND EMBOLISM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Embolism/Embolus; Erythema; Pain; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22791420 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TWO YEARS FOUR MONTHS AND FIFTEEN DAYS POST PORT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN FOR REPEATED VEIN ACCESS, THE PATIENT DEVELOPED PAIN, ERYTHEMA OVER PORT SITE AND DIAGNOSED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Erythema; Pain; Unspecified Infection

  MAUDE report 22697954 ↗
• InjuryJul 25, 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22607061 ↗
• InjuryMay 13, 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 22008258 ↗
• InjuryJun 7, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT SIX MONTHS AND FIVE DAYS POST PORT PLACEMENT, A PUNCTURE OF THE BACK WALL WAS ALLEGEDLY NOTED AND THE PORT WAS ALLEGEDLY LEAKING FROM THE PUNCTURE. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED INFILTRATION AND THE MEDICATION ALLEGEDLY LEAKED INTO THE SURROUNDING TISSUE. REPORTEDLY, THE PORT SYSTEM WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; Infiltration into Tissue; Swelling/ Edema

  MAUDE report 19486462 ↗
• MalfunctionMay 10, 2024

  POWERPORT PLACED SEVERAL MONTHS AGO. TISSUE AROUND HIS PORT WAS SWELLING WITH INJECTIONS. THERE WAS A HOLE IN THE BACK SIDE OF THE PORT. I CAN¿T SAY WHEN THIS HAPPENED, BUT IT WAS LIKELY DUE TO AN ACCESS ATTEMPT. PORT REPLACED.

  Patient problems: Swelling/ Edema

  MAUDE report 19285542 ↗
• InjuryNov 6, 2023

  PT HAD REMOVAL OF A BARD PORT A CATH (POWER PORT) ON (B)(6) 2023 IN THE OPERATING ROOM. PT EXPERIENCED DISCOMFORT AND A BUMP UNDER THE SKIN POST PROCEDURE. PT WAS SEEN BY A DIFFERENT SURGEON IN THE OFFICE ON (B)(6) 2023 WHO REMOVED A SMALL CLIP FRAGMENT OF THE CATHETER UNDER THE INCISION SITE. THE CLIP FRAGMENT WAS NOT SENT TO PATHOLOGY UPON REMOVAL SO HAVE NO WAY OF KNOWING IF THE RETAINED ITEM EVENT WAS DEVICE RELATED OR PRACTITIONER RELATED. REMOVAL OF THE CLIP FRAGMENT OCCURRED IN THE MD OFFICE WITH LOCAL NUMBING MEDICATION AND THE PT RETURNED HOME AFTER THE MINOR PROCEDURE. HISTORY OF ANAL CANCER AND MASS IN THE LEFT CHEST WALL.

  Patient problems: Distress; Foreign Body In Patient

  MAUDE report 18086563 ↗
• InjuryApr 25, 2022Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD NO BLOOD RETURN AND DIFFICULT TO FLUSH. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SWELLING DURING INFUSION TREATMENT AND FLUSHING OF THE DEVICE. REPORTEDLY, THE PORT CAN NO LONGER BE USED FOR TREATMENT DUE TO PATIENTS SYMPTOMS EXPERIENCED DURING USE OF DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14192570 ↗
• InjuryJun 4, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT, THERE WAS ALLEGED PORT DEHISCENCE (PORT EROSION). REPORTEDLY, THE PORT DEVICE WAS REMOVED AND REPLACED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 10117801 ↗
• InjuryJun 4, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT, THERE WAS ALLEGED PORT DEHISCENCE (PORT EROSION). REPORTEDLY, THE PORT DEVICE WAS REMOVED AND REPLACED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 10117763 ↗
• MalfunctionApr 15, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1806061 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO CONSEQUENCES. THE MALE PATIENT'S AGE, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963908 ↗
• MalfunctionJan 16, 2020No Display/Image; Material Deformation; No Display/Image; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 1806061 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FAILURE TO DISPLAY AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599199 ↗
• MalfunctionNov 27, 2018Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED POWERPORT WAS PLACED IN THE PATIENT. THE PORT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104962 ↗