PowerPort ClearVUE 1678300Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741110801), received between Apr 16, 2020 and Sep 25, 2026 — classified as 1 death, 20 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 8, 2018Class IICompleted

   The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

   Z-1764-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Material Protrusion/Extrusion

  A patient underwent a port placement procedure using the PowerPort ClearVUE. It was reported that, for approximately one year the catheter had not been flushed. The patient further reported pain at the port site and stated that the port appeared to be protruding more than usual. There was no reported patient injury.

  Patient problems: Pain

  MAUDE report 50896541 ↗
• InjuryAug 18, 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 50296985 ↗
• InjuryJul 27, 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 sepsis secondary to an unspecified infection. However, the current status of the patient remains unknown.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50034015 ↗
• InjuryJul 6, 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 25713251 ↗
• InjuryApr 6, 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 24788447 ↗
• InjuryFeb 25, 2026Device Appears to Trigger Rejection; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT HAD ALLEGEDLY MIGRATED. IT WAS ALSO REPORTED THAT THE PATIENT HAD DEVELOPED A FIBRIN SHEATH. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 24440365 ↗
• MalfunctionFeb 12, 2026No Display/Image

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE BY USING THE POWERPORT CLEARVUE ISP. IT WAS REPORTED THAT DURING THE PROCEDURE, THE EXPECTED RADIOPAQUE IMAGE WAS NOT ALLEGEDLY OBSERVED. THE PORT WAS SUBSEQUENTLY REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320103 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24206593 ↗
• DeathJan 8, 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 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 24000714 ↗
• InjuryDec 11, 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 WAS DIAGNOSED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23775741 ↗
• InjuryNov 5, 2025Expulsion; Expulsion

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, EROSION WAS OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 23475379 ↗
• InjurySep 19, 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 23093601 ↗
• InjurySep 4, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE THE WIRE IN THE KIT ALLEGEDLY GOT STUCK IN PATIENT'S HEART. DURING THE RETRIEVAL ATTEMPTS THE PATIENT DEVELOPED TACHYCARDIA AND MULTIPLE EPISODES OF TRANSIENT ARRHYTHMIA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 22961326 ↗
• MalfunctionSep 2, 2025Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT THERE WAS SOME WHITE POWDER LOCATED IN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929849 ↗
• InjuryJul 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 PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22540269 ↗
• InjuryJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22182246 ↗
• InjuryJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD DEVELOPED UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22182161 ↗
• MalfunctionMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO-THREE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCING PAIN AT THE INSERTION SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 22002472 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22001787 ↗
• MalfunctionFeb 21, 2025Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PORT ALLEGEDLY BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431434 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED THE SITE WAS RED AND SLIGHTLY SWOLLEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20731662 ↗
• InjuryOct 29, 2024Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY DIFFICULT TO FLUSH AND ENDED WITH A PULMONARY EMBOLISM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 20563304 ↗
• InjuryOct 25, 2024Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT ALLEGEDLY COULD NOT BE FLUSHED WITH PULMONARY EMBOLISM. IT WAS ALSO REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED STABBING PAIN AT THE PORT SITE. FURTHERMORE, THE PATIENT ALSO HAS A LABORED BREATHING WITH THE CHEST PAIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Pulmonary Embolism

  MAUDE report 20530777 ↗
• InjuryApr 14, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE J TIP ON THE WIRE ALLEGEDLY GOT CAUGHT IN THE HEART MUSCLE. IT WAS FURTHER REPORTED THAT THE DEVICE RETRACTED WITH A PIECE OF MUSCLE DUE TO WIRE CAUGHT IN THE HEART AND IT WAS FREED WITH MUCH RESISTANCE. THE CURRENT STATUS OF THE PATIENT IS REPORTED TO BE STABLE.

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

  MAUDE report 19102870 ↗
• MalfunctionJul 14, 2023Fracture; Loose or Intermittent Connection; Material Separation; Fracture; Loose or Intermittent Connection; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, THERE WAS A GAP WHILE ATTACHING THE CATHETER TO THE HUB USING THE CATHETER LOCK, THE CATHETER ALLEGEDLY DIDN¿T GO ALL THE WAY DOWN TO THE END OF THE HUB OF THE PORT. IT WAS FURTHER REPORTED THAT THE TOP PIECE OF THE PORT THAT HOOKS INTO THE CATHETER ALLEGEDLY BROKE AND WAS DISLODGED IN THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323350 ↗