PowerPort, ChronoFlex 1716000Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00801741026744), received between Apr 26, 2018 and Sep 30, 2026 — classified as 4 deaths, 81 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Integrity Problem

  A patient underwent a port removal procedure because treatment was no longer required. The port was implanted on (b)(6) 2026, and removed on (b)(6) 2026. During the removal procedure, Interventional Radiology staff observed that the septum of the purple PowerPort was damaged beyond normal wear and tear. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943533 ↗
• InjurySep 25, 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 50894478 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort Slim. On (b)(6) 2026, upon removal, damage was observed on the silicone portion of the port. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881886 ↗
• MalfunctionSep 24, 2026Tear, Rip or Hole in Device Packaging

  On (b)(6) 2026, a patient underwent a port placement procedure using PowerPort Slim. Prior to the procedure, during inspection, it was noted that the tunneler in two port kits had breached the sterile barrier of the packaging. The procedure was completed using another device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880531 ↗
• MalfunctionSep 24, 2026Tear, Rip or Hole in Device Packaging

  On (b)(6) 2026, a patient underwent a port placement procedure using PowerPort Slim. Prior to the procedure, during inspection, it was noted that the tunneler in two port kits had breached the sterile barrier of the packaging. The procedure was completed using another device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880530 ↗
• InjurySep 7, 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 50646229 ↗
• MalfunctionAug 13, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231624 ↗
• 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 REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25650919 ↗
• InjuryJun 24, 2026Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED, AND FRAGMENT MIGRATED TO SUBCUTANEOUS TISSUES ABOVE CLAVICLE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 25605481 ↗
• InjuryJun 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25604929 ↗
• InjuryMay 26, 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 25280333 ↗
• InjuryMay 25, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND OCCLUSION. FURTHER, FIBRIN SHEATH FORMATION WAS OBSERVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25268509 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT SLIM. AFTER SOME TIME, THE PATIENT EXPERIENCED ITCHING AT THE INSERTION SITE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Itching Sensation

  MAUDE report 25180162 ↗
• InjuryApr 28, 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 25011197 ↗
• MalfunctionApr 20, 2026Fracture

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWER PORT SLIM IMPLANTABLE PORT. DURING THE PROCEDURE, THE INTRODUCER SHEATHS WAS ALLEGEDLY SHREDDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922355 ↗
• MalfunctionApr 20, 2026Fracture

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWER PORT SLIM IMPLANTABLE PORT. DURING THE PROCEDURE, THE INTRODUCER SHEATHS WAS ALLEGEDLY SHREDDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922351 ↗
• InjuryApr 16, 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 24893819 ↗
• 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, INTRACARDIAC CLOT AND CARDIAC INJURY. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24710588 ↗
• MalfunctionMar 26, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699203 ↗
• 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 REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24659300 ↗
• DeathMar 5, 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 24516411 ↗
• MalfunctionFeb 25, 2026Fracture

  IT WAS REPORTED THROUGH THE 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 24439974 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24386559 ↗
• InjuryFeb 3, 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 24247093 ↗
• InjuryDec 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 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 23895494 ↗