PowerPort ClearVUE, ChronoFlex Silk 1608362Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741108082), received between Jun 7, 2018 and Oct 15, 2025 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 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 23299264 ↗
• InjuryMay 2, 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, PATIENT ALLEGEDLY HAD BLOOD CLOT AND DIAGNOSED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21948248 ↗
• DeathApr 3, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Insufficient Information; Sepsis; Unspecified Infection

  MAUDE report 21760340 ↗
• InjuryApr 17, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THREE MONTHS AND TEN DAYS POST A PORT PLACEMENT, THE PATIENT EXPERIENCED SWELLING AT THE AREA OF NECK. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ACUTE TO SUBACUTE OCCLUSIVE RIGHT LOWER INTERNAL JUGULAR PERICATHETER THROMBUS UNDER COMPUTED TOMOGRAPHY EXAMINATION AND ULTRASOUND IMAGING. FURTHERMORE, THE CATHETER WAS ALLEGEDLY OCCLUDED. REPORTEDLY, THE PLAINTIFF'S CATHETER WAS SURGICALLY REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 19127726 ↗
• InjuryApr 12, 2024Adverse 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: Bacterial Infection; Endocarditis; Unspecified Infection

  MAUDE report 19094425 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO YEARS, TWO MONTHS, AND THIRTY DAYS POST PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, FOR ADMINISTRATION OF CHEMOTHERAPY IN TREATMENT OF BREAST CANCER, THE PATIENT WAS DIAGNOSED WITH A BLOOD INFECTION. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17676005 ↗
• InjuryMar 28, 2019Break; Break

  IT WAS REPORTED THAT UPON REMOVAL OF A PORT DEVICE, THE PORT CATHETER WAS FOUND ALLEGEDLY BROKEN WITH A SEGMENT OF THE PORT CATHETER REMAINING IN CUFF OF THE PORT BODY. IT WAS FURTHER REPORTED THAT THE BROKEN CATHETER SEGMENT MIGRATED TO THE RIGHT VENTRICLE. REPORTEDLY, BOTH SEGMENTS WERE REMOVED. THERE WAS NO REPORT OF PATIENT STATUS POST REMOVAL.

  Patient problems: Injury

  MAUDE report 8462757 ↗
• MalfunctionJun 7, 2018Suction Problem; Obstruction of Flow; Aspiration Issue; Suction Problem; Obstruction of Flow; Aspiration Issue

  IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PACKAGE AND DURING DEVICE PREP, IT WAS NOTED THAT THE CATHETER WAS UNABLE TO ASPIRATE. A NEW DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580482 ↗