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
Recalls naming this device
- 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
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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