PowerPort M.R.I., ChronoFlex 1806060Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741026942), received between Jul 3, 2018 and Aug 19, 2026 — classified as 21 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, sometime after the port placement procedure, the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50319538 ↗
• InjuryJul 9, 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 25771846 ↗
• InjuryJun 16, 2026Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter had allegedly fractured, and patient was diagnosed with an unspecified infection. However, the current status of the patient was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 25518444 ↗
• InjuryApr 29, 2026Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH A FRACTURED CHEST PORT TIP LOCATED IN THE RIGHT ATRIUM. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

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

  MAUDE report 25024626 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection; Adverse 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24724882 ↗
• MalfunctionFeb 16, 2026Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343488 ↗
• MalfunctionJan 22, 2026Separation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING IMPLANTED PORT. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO PULL THE WINGS TO SEPARATE THE SHEATH; HOWEVER, THE SHEATH DID NOT FULLY BREAK. A PORTION OF THE RING AT THE PROXIMAL END REMAINED ATTACHED, AND THE DOCTOR HAD TO CUT IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141994 ↗
• MalfunctionJan 13, 2026Separation Failure

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE IMPLANTED PORT. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO PULL THE WINGS TO SEPARATE THE SHEATH. HOWEVER, THE SHEATH DID NOT FULLY BREAK. A PORTION OF THE RING AT THE PROXIMAL END REMAINED ATTACHED, AND THE DOCTOR HAD TO CUT IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050671 ↗
• MalfunctionJan 13, 2026Separation Failure

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE IMPLANTED PORT. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO PULL THE WINGS TO SEPARATE THE SHEATH. HOWEVER, THE SHEATH DID NOT FULLY BREAK. A PORTION OF THE RING AT THE PROXIMAL END REMAINED ATTACHED, AND THE DOCTOR HAD TO CUT IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050670 ↗
• InjuryDec 16, 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 AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23813508 ↗
• InjuryNov 6, 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 23484111 ↗
• InjuryOct 17, 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 23320959 ↗
• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PORT PLACEMENT OF M.R.I POWER PORT FOR AN UNKNOWN MEDICAL CONDITION. AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGIC REACTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23131104 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION, THROMBOSIS AND FIBRIN SHEATH FORMATION WAS NOTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23093087 ↗
• InjuryAug 27, 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 22901878 ↗
• InjuryAug 22, 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22870820 ↗
• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, PATIENT UNDERWENT BARD MRI POWERPORT ISP IMPLANTABLE PORT PLACEMENT PROCEDURE. ABOUT SOMETIME AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21783607 ↗
• InjuryFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE CATHETER FRACTURED AND MALFUNCTIONED. THE PATIENT ALLEGEDLY DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21395438 ↗
• InjuryJan 31, 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 LATER POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS AND PULMONARY EMBOLISM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 21281457 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AND ONE DAY POST A PORT PLACEMENT, THE PORT ALLEGEDLY NOT FUNCTIONING WELL AND CONCERN REGARDING POTENTIAL INFILTRATION REQUIRING INTERVENTIONAL RADIOLOGY REMOVAL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Infiltration into Tissue

  MAUDE report 20998836 ↗
• InjuryDec 9, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SIX MONTHS AND TWENTY-ONE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED CHEST PAIN. IT WAS FURTHER REPORTED THAT THE TUBING WAS ALLEGEDLY FRACTURED AND CAME APART FROM THE PORT AT THE SITE OF THE PORT. IT WAS FURTHER REPORTED THAT CATHETER SEGMENT MIGRATED TO RIGHT ATRIUM. REPORTEDLY, THE PORT WAS REMOVAL IN INTERVENTIONAL RADIOLOGY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Chest Pain

  MAUDE report 20877672 ↗
• InjuryDec 9, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT ONE MONTH AND THREE DAYS POST A PORT PLACEMENT, THE PORT ALLEGEDLY BECAME DISLODGED FROM THE PORT REQUIRING REMOVAL OF FOREIGN BODY USING INTERVENTIONAL RADIOLOGY. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20877270 ↗
• MalfunctionNov 10, 2023Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT FIVE YEARS, THREE MONTHS AND EIGHTEEN DAYS POST A PORT PLACEMENT, THE PORT ALLEGEDLY HAD NO BLOOD RETURN AT ALL AND WAS UNABLE TO DRAW BLOOD EVEN AFTER PROVIDED WITH A PROCESS CALLED CLOT BUSTER. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY HAD DIFFICULTY IN FLUSHING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110225 ↗
• InjuryMar 21, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AND NINE MONTHS POST PORT PLACEMENT, THE TIP OF THE CATHETER ALLEGEDLY BROKE OFF IN THE SUPERIOR VENA CAVA DURING PORT REMOVAL PROCEDURE. IT WAS FURTHER REPORTED THAT UPON FLUOROSCOPY EXAMINATION IT WAS CONFIRMED THAT A FRAGMENT OF THE CATHETER WAS ALLEGEDLY RETAINED IN THE INTRAVASCULAR SPACE. REPORTEDLY THE RETAINED FRAGMENT WAS REMOVED BY PERCUTANEOUS ENDOVASCULAR RETRIEVAL PROCEDURE. THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS STABLE.

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

  MAUDE report 16581194 ↗
• MalfunctionFeb 8, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THERE WAS ALLEGEDLY DIFFERENT ITEM PRESENT UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16319526 ↗