PowerPort M.R.I., ChronoFlex 5829502Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00801741027406), received between Apr 1, 2019 and Jul 6, 2026 — classified as 1 death, 25 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (30 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 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 25714065 ↗
• InjuryJun 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 25649126 ↗
• DeathMar 6, 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Unspecified Infection

  MAUDE report 24529721 ↗
• InjuryNov 26, 2025Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED AND WAS OCCLUDED. IT WAS ALSO REPORTED THAT THE PATIENT HAD UNSPECIFIED INFECTION, THROMBOSIS AND OCCLUSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23655486 ↗
• 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 INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23520084 ↗
• InjurySep 12, 2024Fluid/Blood Leak; Material Protrusion/Extrusion; Fluid/Blood Leak; Material Protrusion/Extrusion

  IT WAS REPORTED THAT TWENTY-ONE DAYS POST A PORT PLACEMENT, THE CONTRAST EXTRAVASATION WAS ALLEGEDLY OCCURRED WITHIN THE RIGHT CHEST WALL AND SOFT TISSUES, WHILE THE MEDIAL SEPTUM WAS ACCESSED FOR DIAGNOSTIC COMPUTED TOMOGRAPHY SCAN. IT WAS FURTHER REPORTED THAT THE MEDIAL SEPTUM WAS ALLEGEDLY FOUND TO BE PARTIALLY DISLODGED UPON EXPLANTATION. REPORTEDLY, THROUGH A SMALL INCISION, THE INDWELLING PORT WAS DISSECTED FREE AND THE PORT AND ATTACHED CATHETER WERE REMOVED IN THEIR ENTIRETY AND REPLACED WITH A NEW PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 20198553 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SEVEN MONTHS AND ONE DAY POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED THROMBOSIS. REPORTEDLY, THE PORT RESERVOIR AND CATHETER WERE REMOVED IN THEIR ENTIRETY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18569484 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST PORT PLACEMENT PROCEDURE, PATIENT ALLEGEDLY EXPERIENCED INFECTION. IT WAS FURTHER REPORTED THAT PORT WAS REMOVED. REPORTEDLY TEMPORARY PICK LINE WAS PLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15768998 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD FIBRIN SHEATH ISSUE. IT WAS FURTHER REPORTED THAT THE DE-CLOTTING AGENT WAS USED BUT WAS UNSUCCESSFUL. THE PORT WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14730294 ↗
• InjuryFeb 1, 2022Fluid/Blood Leak; Material Protrusion/Extrusion; Fluid/Blood Leak; Material Protrusion/Extrusion

  IT WAS REPORTED THAT POST PORT PLACEMENT PROCEDURE, THE EXTRAVASATION ON THE LATERAL SIDE WAS ALLEGEDLY FOUND. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 13410828 ↗
• MalfunctionJun 28, 2021Difficult to Flush; Suction Problem; Failure to Infuse; Material Protrusion/Extrusion; Difficult to Flush; Suction Problem; Failure to Infuse; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PORT ALLEGEDLY HAD DIFFICULTY IN FLUSHING, INFUSING AND UNABLE TO ASPIRATE. IT WAS FURTHER REPORTED THAT THE SEPTUM HAS BEEN DISLODGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073584 ↗
• InjuryJun 8, 2021Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PORT ALLEGEDLY WOULD RISE WHEN FLUSHED AND BRUISING WAS FOUND AROUND THE SITE. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED AND REPLACED. PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Bruise/Contusion

  MAUDE report 11954869 ↗
• InjuryMay 26, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TWELVE WEEKS POST PORT PLACEMENT, THE DEVICE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EXTRAVASATION. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 11884210 ↗
• InjuryMay 26, 2021Fluid/Blood Leak; Fracture; Material Protrusion/Extrusion; Fluid/Blood Leak; Fracture; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST PORT PLACEMENT PROCEDURE, THE PORT MEDIAL LUMEN FOUND ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT, THE PATIENT EXPERIENCED EXTRAVASATION AND PAIN DURING CONTRAST INJECTION. REPORTEDLY PORT WAS REMOVED AND REPLACED WITH ANOTHER PORT. PATIENT REPORTED STATUS WAS UNKNOWN.

  Patient problems: Extravasation; Pain

  MAUDE report 11883158 ↗
• InjuryMay 10, 2021Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD DIFFICULT TO FLUSH. THE PATIENT EXPERIENCES DISCOMFORT. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 11796228 ↗
• InjuryMay 10, 2021Partial Blockage; Fluid/Blood Leak; Partial Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD OBSTRUCTION OF FLOW AND EXTRAVASATION. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 11796211 ↗
• InjuryMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED EXTRAVASATION. UPON ASSESSMENT, THE LEFT PORT APPEARED RED AND THERE WAS A SMALL OPENING ALONG THE INCISION LINE. REPORTEDLY THE PORT WAS REPLACED ON THE RIGHT SIDE. THE PATIENT HAD REDNESS OF THE SKIN OVER THE PORT SITE. THIS WAS DIAGNOSED AS CELLULITIS AND THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Cellulitis; Extravasation

  MAUDE report 11796143 ↗
• MalfunctionMay 10, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD A MATERIAL PROTRUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796078 ↗
• InjuryMay 6, 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 SOMETIME POST PORT PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY HAD PAIN AND SWELLING. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY HAD EXTRAVASATION OF CONTRAST. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 11782329 ↗
• InjuryMay 6, 2021Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT TWO MONTHS POST PORT DEVICE PLACEMENT, THE PATIENT ALLEGEDLY FELT PAIN. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE LATERAL LUMEN OF THE PORT WAS RUPTURED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11781961 ↗
• MalfunctionMay 6, 2021Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD A FLUSHING DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781940 ↗
• MalfunctionApr 23, 2021Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE DEVICE WAS ALLEGEDLY DIFFICULT TO FLUSH BUT HAD A GOOD BLOOD RETURN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716060 ↗
• InjuryApr 23, 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 POST PORT DEVICE IMPLANT WITHIN THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY EXPERIENCED PAIN, SWELLING, THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) AND EXTRAVASATION. IT WAS FURTHER REPORTED THAT, THE DEVICE ALLEGEDLY LEAKED THE CONTRAST DYE NEXT TO THE PORT LOCATED INSIDE THE CHEST WALL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Extravasation; Pain; Swelling/ Edema

  MAUDE report 11714672 ↗
• MalfunctionApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT WHEN FLUSHING THE DEVICE. IT WAS FURTHER REPORTED THAT BLEEPING OF SKIN WAS NOTED WHEN FLUSHING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11714647 ↗
• InjuryApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE DEVICE ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 11714613 ↗