PowerPort, ChronoFlex 1706060Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741026546), received between May 22, 2018 and Sep 2, 2026 — classified as 24 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, on (b)(6)2021, a patient underwent a port placement procedure via the right subclavian vein. Approximately three months and sixteen days later, on (b)(6)2021, blood culture testing reportedly revealed Staphylococcus aureus bacteremia. On the same date, the right chest mediport was removed. During the removal procedure, purulent material was observed within the port pocket, and cultures were obtained from the pocket and catheter tip. However, the current status of the patient remains unknown.

  Patient problems: Bacteremia; Purulent Discharge

  MAUDE report 50560458 ↗
• InjuryAug 17, 2026Device Appears to Trigger Rejection; Migration

  It was reported through the litigation process that, sometime after the port placement, the device allegedly migrated. Additionally, the patient was diagnosed with thrombosis and pulmonary embolism. However, the current status of the patient was unknown.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 50271764 ↗
• InjuryAug 14, 2026Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured. Additionally, the patient experienced skin perforation. However, the current status of the patient was unknown.

  Patient problems: Skin Erosion

  MAUDE report 50250775 ↗
• InjuryMar 23, 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 24659674 ↗
• InjuryFeb 27, 2026Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, A SMALL NICK WAS IDENTIFIED IN THE CATHETER. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24466299 ↗
• InjuryDec 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, THE PATIENT SUBSEQUENTLY DEVELOPED EXTRAVASATION OF CHEMOTHERAPY MEDICATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 23886699 ↗
• InjuryDec 18, 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, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23836691 ↗
• InjuryDec 8, 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 23736138 ↗
• InjuryNov 10, 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 EXPERIENCED WITH UNSPECIFIED INFECTION, THROMBOSIS AND EMBOLISM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23507707 ↗
• MalfunctionOct 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP, FOR AN UNKNOWN MEDICAL CONDITION. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE AIRGUARD INTRODUCER WAS WET, ALTHOUGH THE PACKAGING AND ALL OTHER KIT CONTENTS WERE DRY. A SECOND KIT WAS THEN OPENED, AND THE SAME WETNESS WAS NOTICED ON THE INTRODUCER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23207774 ↗
• MalfunctionSep 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP, FOR AN UNKNOWN MEDICAL CONDITION. PRIOR TO THE PROCEDURE IT WAS REPORTED THAT THAT THE AIRGUARD INTRODUCER WAS WET, BUT THE PACKAGING AND ALL OTHER KIT CONTENTS WERE DRY. THE OPENED A SECOND KIT AND NOTICED THE SAME WETNESS ON THE INTRODUCER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23178785 ↗
• InjurySep 2, 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 22937136 ↗
• InjurySep 2, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22935858 ↗
• 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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22901499 ↗
• InjuryAug 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22892098 ↗
• InjuryJul 16, 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 22520729 ↗
• InjuryJul 16, 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 22519755 ↗
• InjuryJul 9, 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 DIAGNOSED WITH THROMBOSIS CONDITION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22456082 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, PATIENT UNDERWENT BARD POWERPORT ISP IMPLANTABLE PORT PLACEMENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION. ABOUT SOMETIME AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21966373 ↗
• InjuryMar 10, 2025Fracture; Fracture

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21557618 ↗
• InjuryFeb 18, 2025Device Appears to Trigger Rejection; Expulsion; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacterial Infection; Erythema; Pain; Purulent Discharge; Skin Erosion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21395505 ↗
• InjurySep 29, 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 ALLEGEDLY DEVELOPED AN INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20330186 ↗
• InjuryApr 27, 2022Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT POST PORT IMPLANTATION PROCEDURE, THE PORT ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE FRACTURED PIECES ALLEGEDLY MIGRATED INTO THE HEART. IT WAS FURTHER REPORTED THAT THE FRACTURED COMPONENT REMOVED FROM THE PATIENT BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14217921 ↗
• MalfunctionApr 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE DEVICE ALLEGEDLY BROKE EXTERNALLY WHILE ATTEMPTING TO ATTACH THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693525 ↗
• MalfunctionJul 19, 2019Break; Break

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1706060. PORT & CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS REPORT WAS RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. BOTH PATIENTS ARE FEMALE, ONE PATIENT IS (B)(6) YEARS OF AGE AND IS (B)(6) KGS, THE OTHER PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808880 ↗