PowerPort ClearVUE 1608052Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00801741026423), received between Jun 6, 2018 and Sep 3, 2026 — classified as 1 death, 44 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Component Missing” (12 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 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 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 an unspecified infection. However, the current status of the patient was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50588117 ↗
• InjuryAug 17, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis and superior vena cava (SVC) Syndrome. However, the current status of the patient remains unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50269911 ↗
• MalfunctionMay 19, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE ISP. PRIOR TO THE PROCEDURE, WHEN PRODUCT WAS OPENED TO DROP ONTO STERILE FIELD A PEN MARK WAS NOTED ON THE INSIDE OF THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25213207 ↗
• DeathMay 11, 2026Device Appears to Trigger Rejection; Adverse 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 AND THROMBOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 25134011 ↗
• InjuryApr 17, 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 IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24907223 ↗
• 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24902544 ↗
• InjuryMar 10, 2026Fracture; Device Appears to Trigger Rejection; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24555308 ↗
• InjuryMar 7, 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 24541023 ↗
• MalfunctionMar 6, 2026Component Missing; Packaging Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE BOX WAS EMPTY AND DID NOT CONTAIN ANY PRODUCT INSIDE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528687 ↗
• MalfunctionMar 4, 2026Component Missing; Packaging Problem

  ON (B)(6) 2026, A PATIENT PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE BOX WAS EMPTY AND DID NOT CONTAIN ANY PRODUCT INSIDE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504417 ↗
• MalfunctionFeb 27, 2026Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24467098 ↗
• InjuryJan 29, 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 24207149 ↗
• InjuryDec 31, 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 DEVELOPED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23932287 ↗
• InjuryDec 24, 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23887844 ↗
• InjuryDec 1, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  A POWERPORT CLEARVUE WAS IMPLANTED, AND THE PATIENT REPORTED DIFFICULTY INHALING WHEN THE PORT IS ACCESSED. SHE STATED THAT SHE HAS NO PROBLEM EXHALING, ONLY INHALING. THE PATIENT WENT TO THE ER AND HAD A CHEST X-RAY PERFORMED. SHE WAS INFORMED THAT THE X-RAY WAS NORMAL, BUT THE PORT CATHETER HAD SHIFTED SLIGHTLY AND WAS STILL CONSIDERED ACCEPTABLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 23677566 ↗
• InjuryNov 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 POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23655264 ↗
• InjuryOct 27, 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 23390540 ↗
• InjurySep 30, 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 23177256 ↗
• InjurySep 16, 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23060489 ↗
• InjurySep 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 EXPERIENCED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23023893 ↗
• InjurySep 8, 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 DEVELOPED WITH THROMBOSIS AND BLOOD CLOTS FORMATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22989866 ↗
• InjurySep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2019 A MALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE FOR AN UNSPECIFIED MEDICAL CONDITION UTILIZING THE POWERPORT CLEARVUE IMPLANTABLE PORT. IT WAS REPORTED THAT ON (B)(6) 2025, FIVE YEARS, FOUR MONTHS, AND FIVE DAYS AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED EXTRAVASATION. ON (B)(6) 2025, THE DEVICE WAS REMOVED FROM THE PATIENT.

  Patient problems: Extravasation

  MAUDE report 22975213 ↗
• InjurySep 2, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT ABOUT NINE DAYS LATER, POST A PORT PLACEMENT PROCEDURE FOR SYSTEMIC INDUCTION THERAPY FOR ACUTE MYELOID LEUKEMIA, THE PATIENT HAD DEVELOPED WITH PURULENT DRAINAGE AROUND THE PORT SITE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH BACTERIAL INFECTION, SEPSIS AND EVENTUALLY DEVELOPED SEPTIC SHOCK. FURTHERMORE, THE PATIENT WAS DIAGNOSED WITH ACUTE RENAL FAILURE, LIVER FAILURE AND ATRIAL FIBRILLATION DUE TO INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Atrial Fibrillation; Bacteremia; Bacterial Infection; Hepatitis; Liver Failure; Obstruction/Occlusion; Pressure Sore/Ulcer; Purulent Discharge; Renal Failure; Sepsis; Septic Shock

  MAUDE report 22935892 ↗
• InjuryAug 21, 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 22866755 ↗
• InjuryJul 30, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22661778 ↗