PowerPort, ChronoFlex 1716001Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741026751), received between May 18, 2018 and Sep 30, 2026 — classified as 2 deaths, 16 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 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 50943559 ↗
• DeathJun 18, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25542445 ↗
• InjuryMay 26, 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 25273917 ↗
• InjuryApr 2, 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 AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24763968 ↗
• DeathMar 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24659436 ↗
• InjuryFeb 24, 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24427092 ↗
• InjuryDec 18, 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 DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23837563 ↗
• MalfunctionDec 11, 2025Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN PORT PLACEMENT PROCEDURE USING THE POWERPORT SLIM TI. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PORT COULD NOT DRAW BACK WHILE THE CATHETER WAS IN THE SALINE BOWL, AND AIR BUBBLES WERE OBSERVED DESPITE MULTIPLE CHECKS. THE TEAM VERIFIED ALL CONNECTIONS, CHANGED SYRINGES, AND REPLACED THE ACCESS NEEDLE, BUT THE ISSUE PERSISTED. CONSEQUENTLY, THE DECISION WAS MADE NOT TO USE THE AFFECTED PORT AND INSTEAD PLACE A DIFFERENT PORT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777731 ↗
• MalfunctionNov 13, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539811 ↗
• InjuryNov 5, 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 23474792 ↗
• InjuryOct 23, 2025Disconnection; Fluid/Blood Leak; Blocked Connection; Disconnection; Fluid/Blood Leak; Blocked Connection

  A 83-YEAR-OLD FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT SLIM. POST PROCEDURE ON (B)(6) 2025 WHILE ON THIRD CHEMOTHERAPY TREATMENT, THE PORT WAS ALLEGEDLY FOUND LEAKING AND THE PATIENT ALLEGEDLY EXPERIENCED SWELLING ABOVE THE PORT. EXTRAVASATION AND INFILTRATING INTO TISSUES HAD OCCURRED AROUND THE PORT. REPORTEDLY, PARTIAL DISCONNECTION OF THE PORT CATHETER WAS FOUND AT THE HUB OF THE METAL PORT DEEMING THE PORT DYSFUNCTIONAL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Infiltration into Tissue; Swelling/ Edema

  MAUDE report 23365524 ↗
• 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 APPROXIMATELY ONE MONTHS AND FIFTEEN DAYS POST PORT PLACEMENT PROCEDURE FOR REPEATED VEIN ACCESS, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22518092 ↗
• InjuryJan 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21132783 ↗
• InjuryNov 13, 2024Difficult to Flush; Fracture; Material Separation; Suction Problem; Migration; Difficult to Flush; Fracture; Material Separation; Suction Problem; Migration

  IT WAS REPORTED THAT SEVEN MONTHS AND EIGHTEEN DAYS POST A PORT PLACEMENT PROCEDURE IN THE RIGHT CHEST AREA VIA RIGHT INTERNAL JUGULAR VEIN, ALLEGEDLY THERE WAS AN ISSUE WITH FLUSHING THE DEVICE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD AN ASPIRATION ISSUE. FURTHERMORE, UPON REMOVAL OF THE DEVICE IT WAS NOTED THAT THE DEVICE WAS ALLEGEDLY BROKE OFF. REPORTEDLY, THE BROKEN CATHETER APPEARED TO BE IN THE RIGHT ATRIA/VENTRICLE ON FLUOROSCOPY AND THE BROKEN DEVICE WAS REMOVED THROUGH INTERVENTIONAL RADIOLOGY. THE PATIENT WAS DISCHARGED HOWEVER, THE PATIENT IS REPORTED TO BE STABLE NOW.

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

  MAUDE report 20671725 ↗
• InjuryNov 5, 2024Expulsion; Expulsion

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DEVELOPED WITH INFECTION AND EROSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 20608471 ↗
• InjuryMay 14, 2024Suction Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Suction Problem; Material Twisted/Bent; 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 THROMBOSIS AND PULMONARY EMBOLISM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 19308491 ↗
• InjuryJan 8, 2024Difficult to Flush; Device Appears to Trigger Rejection; Difficult to Remove; Suction Problem; Difficult to Flush; Device Appears to Trigger Rejection; Difficult to Remove; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY DIFFICULT TO FLUSH, HAD TO USE EXTRA FORCE AND DID NOT PROVIDE A BLOOD RETURN. IT WAS FURTHER REPORTED THAT A DYE STUDY WAS PERFORMED, AND FIBRIN SHEATH WAS NOTED. IT WAS FURTHER REPORTED THAT THE PORT WAS TOO ATTACHED TO THE CHEST WALL AND CANNOT BE REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 18462751 ↗
• MalfunctionDec 21, 2023Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, WHEN THE PHYSICIAN WENT TO ADJUST AND STRAIGHTEN THE GUIDEWIRE, THE TIP OF THE DEVICE ALLEGEDLY CAME APART IN THE PHYSICIAN'S HAND. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371487 ↗
• InjuryOct 4, 2023Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO YEARS, ONE MONTH, AND THREE DAYS POST PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN, THE PATIENT ALLEGEDLY DEVELOPED BLOOD CLOTS AROUND THE PORT. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER WAS ALLEGEDLY MIGRATED TO THE INTERNAL JUGULAR VEIN. REPORTEDLY, THE PORT WITH ITS CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 17866862 ↗
• MalfunctionSep 2, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT, THE COMPUTED TOMOGRAPHY MARKERS WERE ALLEGEDLY NOT VISIBLE UNDER CHEST X-RAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674937 ↗
• InjuryMay 22, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT ONE YEAR POST PORT REMOVAL, THE CATHETER ALLEGEDLY FRACTURED AND MIGRATED AND REMAINED OVER THE PULMONARY ARTERY. IT WAS FURTHER REPORTED THAT THE REMAINED CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16974608 ↗
• MalfunctionDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY EXPERIENCED SYMPTOMS OF FEVER AND COLD . THERE IS NO INFORMATION REGARDING THE TREATMENT FOR THE FEVER AND COLD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949290 ↗
• MalfunctionMay 13, 2022Unexpected Therapeutic Results

  PORT MALFUNCTION UPON INSERTION, EXPLANTED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14409302 ↗
• MalfunctionApr 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD BROKE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14157980 ↗
• InjuryJun 4, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT, THERE WAS ALLEGED PORT DEHISCENCE (PORT EROSION). REPORTEDLY, THE PORT DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Skin Erosion

  MAUDE report 10117525 ↗