PowerPort ClearVUE 1668362Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741110740), received between Oct 18, 2019 and Aug 14, 2026 — classified as 1 death, 27 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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-1761-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Device Appears to Trigger Rejection

  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 was unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50251853 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. POST THE IMPLANTATION, IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED BURNING SENSATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Burning Sensation

  MAUDE report 25108773 ↗
• InjuryMar 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24602920 ↗
• InjuryMar 3, 2026Device Appears to Trigger Rejection; Difficult to Remove; Migration

  IT WAS REPORTED THROUGH LITIGATION THAT, SOMETIME AFTER THE PORT PLACEMENT, THE IMPLANTED PORT ALLEGEDLY MIGRATED, NECESSITATING SURGICAL INTERVENTION. IN ADDITION, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS, AND A FIBRIN SHEATH WAS OBSERVED DURING EVALUATION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24493046 ↗
• InjuryFeb 20, 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 24398835 ↗
• InjuryFeb 12, 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 WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24321378 ↗
• InjuryFeb 6, 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 24276528 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE BY USING THE POWERPORT CLEARVUE ISP. IT WAS REPORTED THAT AFTER SOME TIME, IT WAS NOTED THAT THE PATIENT WAS ALLEGEDLY EXPERIENCING A SCRATCHING SENSATION NEAR THE VEIN, AND THE AREA APPEARED IRRITATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Itching Sensation

  MAUDE report 23904653 ↗
• 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 PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23895133 ↗
• MalfunctionOct 30, 2025Unsealed Device Packaging; Component Missing; Unsealed Device Packaging; Component Missing

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY FOUND MISSING FROM THE PACKAGE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT SEALED PROPERLY BECAUSE IT WAS NEVER PUT IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423664 ↗
• InjuryOct 29, 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 23412403 ↗
• InjuryOct 24, 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 23378855 ↗
• MalfunctionSep 5, 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. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975125 ↗
• InjuryJul 24, 2025Obstruction of Flow; Obstruction of Flow

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

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

  MAUDE report 22585772 ↗
• InjuryJul 24, 2025Obstruction of Flow; Obstruction of Flow

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

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

  MAUDE report 22585758 ↗
• InjuryJul 24, 2025Obstruction of Flow; Obstruction of Flow

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

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

  MAUDE report 22585756 ↗
• InjuryJul 22, 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: Bacterial Infection; Unspecified Infection

  MAUDE report 22563435 ↗
• InjuryJun 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 A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22217400 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22192225 ↗
• InjuryJun 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 ALLEGEDLY DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Drug Resistant Bacterial Infection; Pulmonary Embolism; Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22147872 ↗
• MalfunctionMay 26, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  ON (B)(6) 2025, WHEN THE PRODUCT WAS TAKEN OUT OF THE SHIPPING BOX, OPENED THE OUTSIDE BOX PACKAGE, THE TUNNELER WAS STICKING OUT OF THE PLASTIC A HOLE WAS CREATED FROM IT. PRODUCT WAS NO LONGER STERILE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083082 ↗
• InjuryFeb 21, 2025Expulsion; Expulsion

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD FIFTY PERCENTAGE OF THE PORT ERODED THROUGH THE SKIN. IT WAS FURTHER REPORTED THAT THE SURROUNDING ERYTHEMA WAS NOTED WITHOUT INDURATION, PURULENT DRAINAGE, OR EVIDENCE OF NECROSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Erythema; Necrosis; Skin Erosion

  MAUDE report 21429625 ↗
• InjuryFeb 21, 2025Expulsion; Expulsion

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT ALLEGEDLY ERODED THROUGH THE SKIN. IT WAS FURTHER REPORTED THAT UPON INSPECTION IT WAS NOTED THAT THE CRANIAL HALF OF THE RESERVOIR WAS VISIBLE WITH SKIN BREAKDOWN AND ERYTHEMA AROUND THE HEALED INCISION. REPORTEDLY, THERE WAS NO EVIDENCE OF INFECTION, AND NO SWELLING OR DRAINAGE WAS PRESENT. ADDITIONALLY, THE PORT WAS REMOVED BY THE INTERVENTIONAL RADIOLOGIST AND THE PATIENT WAS PLACED ON ANTIBIOTICS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Erythema; Skin Erosion

  MAUDE report 21429545 ↗
• MalfunctionOct 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE FLAP OF SILICONE ON THE BASE OF THE PORT WAS ALLEGEDLY NOT FULLY ADHERED TOGETHER. IT WAS FURTHER REPORTED THAT THE PORT PLACED IN THE POCKET TO TEST FOR SIZE WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436193 ↗
• InjurySep 16, 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 AN ALLERGIC REACTION ON FACE. IT WAS FURTHER REPORTED THAT THE PATIENT'S FACE HAD ALLEGEDLY BECAME MORE RED AND PUFFY. FURTHERMORE, THE PATIENT WAS PROVIDED WITH AN ANTIBIOTIC CREAM AND BENADRYL TO TREAT THE ALLERGIC REACTION ON FACE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20221619 ↗