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PowerPort ClearVUE 1676300Recalls & reported problems

Bard Access Systems, Inc. · PowerPort ClearVUE Slim with Smooth Septum, 6F Polyurethane Catheter, Suture Plugs, Intermediate Kit · Class 2 · Implant

All models of PowerPort ClearVUE (27)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
16
Deaths reported
0
Injuries reported
9
Recalls naming it
1

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741110764), received between Apr 18, 2019 and May 12, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 3 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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-1762-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem8
  • Blocked Connection2
  • Fracture2
  • Obstruction of Flow2
  • Break1
  • Device Dislodged or Dislocated1
  • Difficult or Delayed Separation1
  • Material Puncture/Hole1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Unspecified Infection5
  • Chest Pain1
  • Hemorrhage/Blood Loss/Bleeding1
  • No Consequences Or Impact To Patient1
  • Pulmonary Embolism1
  • Thrombosis/Thrombus1

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 12, 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 25147784 ↗
  • InjuryMar 18, 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 24625119 ↗
  • InjuryNov 25, 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 THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23644932 ↗
  • InjuryOct 29, 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 23411066 ↗
  • InjuryAug 3, 2025Migration; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH CHEST PAIN AND THERE WAS MIGRATION OF PORT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Chest Pain

    MAUDE report 22696273 ↗
  • InjuryJun 19, 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, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22291522 ↗
  • 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 UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22217399 ↗
  • InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY SIX MONTHS AND TWENTY-EIGHT DAYS LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH ACUTE PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Pulmonary Embolism

    MAUDE report 22156733 ↗
  • MalfunctionApr 10, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE ACCESS NEEDLE ALLEGEDLY CRACKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16709153 ↗
  • MalfunctionMar 20, 2023Fracture; Suction Problem; Fracture; Suction Problem

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE ACCESS NEEDLE ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY HAD SUCTION PROBLEM AND THE EDGES WERE TOO SHARP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16579004 ↗
  • MalfunctionNov 23, 2022Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD HOLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15850314 ↗
  • InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY NOTICED BLEEDING IN THE INCISION OVER THE PORT BODY. IT WAS FURTHER REPORTED THAT IT WAS NOT INFECTED AND NO HEMATOMA WAS NOTED AND PRESSURE DRESSING WAS APPLIED. PATIENT CURRENT STATUS WAS UNKNOWN.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 12164648 ↗
  • MalfunctionJun 3, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

    IT WAS REPORTED DURING PORT PLACEMENT PROCEDURE, THE AIR GUARD VALVE PEEL AWAY SHEATH WAS ALLEGEDLY DIFFICULT TO SEPARATE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11927527 ↗
  • MalfunctionNov 29, 2020Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

    IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE HCP WAS ALLEGEDLY UNABLE TO ACCESS THE PORT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10916657 ↗
  • MalfunctionNov 23, 2020Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

    IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE HCP ALLEGEDLY HAD A DIFFICULT TIME ACCESSING THE PORT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10882515 ↗
  • MalfunctionApr 18, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

    THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 1676300 IMPLANTABLE PORT EXPERIENCED A BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8527688 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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Sources and updates

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