PowerPort ClearVUE 5668362Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741110757), received between Jul 2, 2018 and Sep 29, 2026 — classified as 25 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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-1767-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture; Device Appears to Trigger Rejection; Material Separation; Migration

  It was reported through the litigation process that, sometime after the port placement, the catheter tip allegedly retracted and migrated, requiring port exchange or revision. Additionally, a catheter fragment allegedly migrated to the lower right internal jugular vein. Further, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50928874 ↗
• InjurySep 23, 2026Device Appears to Trigger Rejection

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

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 50864168 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, sometime after the port placement procedure, the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50033150 ↗
• InjuryJun 29, 2026Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT ALLEGEDLY MIGRATED THROUGH THE SKIN. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25648923 ↗
• InjuryMay 21, 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 25242699 ↗
• InjuryMay 13, 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 25157307 ↗
• InjuryApr 21, 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24936437 ↗
• MalfunctionFeb 9, 2026Reflux within Device; Air/Gas in Device

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP IMPLANTABLE PORT. POST PROCEDURE, DURING THE FIRST ATTEMPTED ACCESS FOR CHEMOTHERAPY INFUSION, NEEDLE INSERTION RESULTED IN ASPIRATION OF CLEAR FLUID INSTEAD OF BLOOD RETURN. THE CLINICIAN NOTED A BUBBLE OF FLUID SURROUNDING THE PORT SITE. ALTHOUGH THE FLUID WAS DRAINED, IT REPEATEDLY REACCUMULATED. DUE TO THE PERSISTENT FLUID AND THE INABILITY TO ADMINISTER CHEMOTHERAPY THROUGH THE PORT, THE PHYSICIAN DETERMINED THAT PORT REMOVAL WAS NECESSARY. THERE WERE NO SIGNS OF INFECTION, AND ANALYSIS OF THE ASPIRATED FLUID CONFIRMED IT WAS NON INFECTIOUS. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 24301040 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE IT WAS NOTED THAT THE PORT WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289096 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE IT WAS NOTED THAT THE PORT WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288961 ↗
• InjuryDec 12, 2025Fracture; Fracture

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23787348 ↗
• InjuryDec 11, 2025Fracture; Fracture

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23775740 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Obstruction of Flow; Device Appears to Trigger Rejection; Obstruction of Flow

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND THROMBOSIS. ADDITIONALLY, FIBRIN SHEATH FORMATION AND OCCLUSION WERE OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23753220 ↗
• InjuryDec 4, 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 23714133 ↗
• MalfunctionNov 11, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE ISP. IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND WITH MISSING SOME ITEMS. REPORTEDLY, THE DEVICE WAS ALLEGEDLY FOUND WITH WRONG ITEMS IN KIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519823 ↗
• MalfunctionOct 23, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025 A PATIENT PREPARED FOR A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE ISP. DURING THE PREPARATION PROCEDURE, IT WAS REPORTED THAT THE SLIP-TIP SYRINGE ALLEGEDLY FOUND BROKEN. REPORTEDLY, UPON OPENING THE PACKAGE, A FRACTURE WAS IDENTIFIED, WHICH RESULTED IN THE MATERIAL SEPARATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367755 ↗
• InjuryOct 21, 2025Fracture; Fracture

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

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23345181 ↗
• InjuryOct 15, 2025Fracture; Fracture

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

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23287783 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE THE PORT WAS ALLEGEDLY FOUND RED, PUFF AND DRAINING THICK FLUID THAT CRUSTED OVER. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED SHORTNESS OF BREATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Dyspnea

  MAUDE report 22640764 ↗
• InjuryJul 28, 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 22628797 ↗
• InjuryJul 28, 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 THROMBOSIS CONDITION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22628589 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH THROMBOSIS AND OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22200451 ↗
• InjuryMay 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 WAS ALLEGEDLY DIAGNOSED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22083397 ↗
• InjuryFeb 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 ABOUT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT WAS ALLEGEDLY DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Unspecified Infection; Urinary Tract Infection

  MAUDE report 21469376 ↗
• InjuryJan 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 POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21177714 ↗