PowerPort M.R.I., ChronoFlex 1829570Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741027192), received between Dec 4, 2018 and Sep 28, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fluid/Blood Leak

  It was reported through the litigation process that, sometime after the port placement, the port allegedly leaked fluid during treatment. Additionally, the patient was diagnosed with an unspecified infection, pain, and cellulitis around the chemo port. However, the current status of the patient was unknown.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 50912639 ↗
• InjuryMay 11, 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 25134007 ↗
• InjuryDec 4, 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 23712842 ↗
• InjuryOct 15, 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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23288357 ↗
• MalfunctionSep 10, 2025Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

  A PATIENT UNDERWENT FOR PORT PLACEMENT PROCEDURE USING POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F. IT WAS REPORTED THAT POST PORT PLACEMENT, THE PATIENT WAS CONCERNED THAT THERE IS A BLOCKED PRODUCT AT THE TIP OF CATHETER FOR AN OCCLUSION AND FURTHER REPORTEDLY THE PATIENT ALLEGEDLY ASKING MORE RELEVANT INFORMATION ABOUT PORT'S FLUSHING VOLUMES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013700 ↗
• InjuryJul 28, 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 WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22631618 ↗
• InjuryJul 28, 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 WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22631428 ↗
• InjuryJun 10, 2025Restricted Flow rate; Blocked Connection; Restricted Flow rate; Blocked Connection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD POOR FLOW AND DIFFICULTY ACCESSING- REQUIRES TPA FREQUENTLY. FURTHERMORE, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22174655 ↗
• MalfunctionDec 13, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT ALLEGEDLY HAD RECURRENT OCCLUSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922192 ↗
• MalfunctionDec 13, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT ALLEGEDLY HAD RECURRENT OCCLUSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921565 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT FOUR MONTHS AND FOURTEEN DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH RIGHT ARM SWELLING. FURTHERMORE, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH RIGHT SUBCLAVIAN AND AXILLARY VENOUS THROMBOSIS UNDER ULTRASOUND IMAGING OF RIGHT UPPER EXTREMITY. REPORTEDLY, THE CATHETER AND PORT WERE REMOVED IN ITS ENTIRETY AND DISCARDED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20144004 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT TWO YEARS, FOUR MONTHS AND SIXTEEN DAYS POST A PORT PLACEMENT IN THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION AND PULMONARY EMBOLISM SECONDARY TO PORT. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism; Unspecified Infection

  MAUDE report 19770329 ↗
• MalfunctionMay 26, 2023Fluid/Blood Leak; Fracture; Material Protrusion/Extrusion; Fluid/Blood Leak; Fracture; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY LEAKED WHEN FLUSHING. IT WAS ALSO REPORTED THAT THE UPON PALPATION AND INSPECTION PRIOR TO REMOVAL, LATERAL LUMEN WAS ALLEGEDLY IRREGULAR AND RAISED. REPORTEDLY THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009145 ↗
• InjuryFeb 22, 2023Fluid/Blood Leak; Expulsion; Material Protrusion/Extrusion; Fluid/Blood Leak; Expulsion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY FOUND LEAKING. IT WAS FURTHER REPORTED THAT WHEN CHEMO WAS INJECTED INTO THE PORT, THE PATIENT ALLEGEDLY EXPERIENCED COMPLETE SKIN BURN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 16416303 ↗
• InjuryJul 2, 2021Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PORT ALLEGEDLY HAD EXTRAVASATION. IT WAS FURTHER REPORTED THAT PORT WAS REMOVED FORM THE PATIENT. PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 12105731 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem

  BARD POWER PORT DUO 9.5 F PLACED ON (B)(6) 2021. ON (B)(6) 2021 CT CHEST / ABDOMEN DONE WITH CONTRAST AT ANOTHER FACILITY. REPORTED NOTED THAT THERE WAS EXTRAVASATION IN THE PORT-A-CATH. PT PRESENTED TO HAVE PORT CHANGED. THIS PORT IS PART OF A URGENT MEDICAL RECALL BY BARD ACCESS SYSTEMS.

  Patient problems: Extravasation

  MAUDE report 11752165 ↗
• InjuryApr 22, 2021Fluid/Blood Leak; Material Protrusion/Extrusion; Fluid/Blood Leak; Material Protrusion/Extrusion

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE SEPTUM OF THE DEVICE POPPED OFF WHEN BEING POWER INJECTED. THE PATIENT EXPERIENCED EXTRAVASATION OF CONTRAST UNDER THE SKIN AND THE PORT WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 11705013 ↗
• MalfunctionOct 27, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1829570 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED OBSTRUCTION OF FLOW AND SUCTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. FEMALE PATIENTS' AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742581 ↗
• MalfunctionApr 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1829570. PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED DEVICE DISLODGED OR DISLOCATED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS 68 YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS 180 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529015 ↗
• MalfunctionDec 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AFTER PORT IMPLANTATION, THE PORT WAS DIFFICULT TO INFUSE AND WAS ALLEGEDLY UNABLE TO ASPIRATE. IT WAS FURTHER REPORTED ADDITIONAL ATTEMPTS VIA CAHTFLO/TPA WERE COMPLETED TO TWICE AND WERE UNABLE TO ASPIRATE. A WEEK AFTER FAILURE TO ASPIRATE OCCURRED, A DYE STUDY WAS COMPLETED AND FOUND A LEAK DISTAL TO THE CLAVICLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131308 ↗