PowerPort, ChronoFlex 4708060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741027284), received between Sep 28, 2018 and Mar 30, 2026 — classified as 2 deaths, 9 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24725974 ↗
• InjuryMar 30, 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 24725773 ↗
• InjuryMar 30, 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 REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24725296 ↗
• DeathOct 31, 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 AND LATER PASSED AWAY. THE CAUSE OF THE DEATH WAS UNKNOWN.

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

  MAUDE report 23434224 ↗
• InjurySep 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 23071335 ↗
• InjurySep 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23048456 ↗
• InjuryJul 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, ON (B)(6) 2023, A PORT WAS IMPLANTED VIA THE LEFT SUBCLAVIAN VEIN IN A PATIENT FOR A HISTORY OF CROHN DISEASE. APPROXIMATELY FOUR MONTHS AND TWENTY-FIVE DAYS LATER, ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. APPROXIMATELY ONE MONTH AND FIFTEEN DAYS LATER, ON (B)(6) 2023, THE PATIENT EXPERIENCED SEPSIS AND SEPTIC SHOCK. SUBSEQUENTLY, THE BLOOD CULTURES ON THE SAME DAY WERE POSITIVE FOR GRAM NEGATIVE BACTERIA. FURTHER, THE INFECTED PORT WAS REMOVED ON (B)(6) 2023, AND PURULENCE WAS OBSERVED DURING THE REMOVAL. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Bacterial Infection; Purulent Discharge; Sepsis; Septic Shock; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22540100 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; 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: Bacterial Infection; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22138821 ↗
• InjuryNov 8, 2023Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO MONTHS AND TWENTY-THREE DAYS POST PORT PLACEMENT FOR THE PURPOSE OF ONGOING CHEMOTHERAPY FOR BREAST CANCER, THE PATIENT WAS DIAGNOSED WITH CANDIDEMIA INFECTION. IT WAS FURTHER REPORTED THAT THE PORT WAS ERODED OVER THE SKIN AND EXPOSED. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED CHEST PAIN. REPORTEDLY, THE PATIENT UNDERWENT SURGERY TO REMOVE THE INFECTED PORT AND NEW PORT WAS IMPLANTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Chest Pain; Fungal Infection

  MAUDE report 18090129 ↗
• DeathMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY TWO YEARS POST PORT DEVICE IMPLANT, THE PATIENT ALLEGEDLY EXPIRED; HOWEVER, PATIENT'S CAUSE OF DEATH SURROUNDING OR RELATED TO THE DEVICE WAS NOT PROVIDED.

  Patient problems: Death

  MAUDE report 10103138 ↗
• InjurySep 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE FACILITY THAT THEY RECEIVED A LETTER FROM THE PATIENT STATING THAT APPROXIMATELY 5 MONTHS AFTER THE PORT WAS REMOVED, IT WAS DISCOVERED THAT THE CATH LOCK WAS NOT REMOVED. THE CATH LOCK WAS REMOVED AT ANOTHER FACILITY. PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 7920206 ↗