PowerPort ClearVUE 1616000Recalls & reported problems
Bard Access Systems, Inc. · PowerPort ClearVUE Slim Implantable Port with Attachable 6F Polyurethane Open-Ended Single-Lumen Venous Catheter Intermediate Kit · Class 2 · Implant
All models of PowerPort ClearVUE (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPort ClearVUE implanted port is a small device under the skin with a catheter that gives access to a vein for infusions. Of its 127 reports, 62 are malfunctions and 59 are injuries, and 6 describe deaths; many describe infections and blood clots after placement, and some describe fractures or leaks. Several injury reports come from legal records. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 122
- Deaths reported
- 6
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00801741026447), received between Jun 18, 2018 and Aug 27, 2026 — classified as 6 deaths, 55 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem42
- Fracture19
- Fluid/Blood Leak13
- Deformation Due to Compressive Stress9
- Difficult to Remove8
- Inaccurate Information8
- Material Separation6
- Migration6
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Unspecified Infection30
- Thrombosis/Thrombus17
- No Consequences Or Impact To Patient9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Insufficient Information4
- Swelling/ Edema4
- Bacterial Infection3
Recent adverse event reports
The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Device Appears to Trigger Rejection; Obstruction of Flow
It was reported through the litigation process that, sometime after the port placement, the catheter allegedly occluded. Additionally, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50471323 ↗MalfunctionAug 14, 2026Fluid/Blood Leak; Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249310 ↗InjuryAug 13, 2026Device Appears to Trigger Rejection
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 was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50232583 ↗InjuryAug 5, 2026Fracture; Material Separation; Migration
It was reported through the litigation process that, sometime after the port placement, the catheter had allegedly fractured. Additionally, the fractured fragment migrated to the intracardiac region and embolized. However, the current status of the patient was unknown.
Patient problems: Embolism/Embolus
MAUDE report 50137969 ↗InjuryJul 27, 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 50032309 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
ON (b)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE SLIM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ZAPPING TYPE PAIN APPROXIMATELY ONE TO TWO INCHES FROM THE IMPLANTED PORT SITE. THE PAIN BEGAN THE PREVIOUS DAY DURING NORMAL DAILY ACTIVITIES. THE PATIENT STATED THAT THE DEVICE HAD BEEN USED FOR PERIODIC INFUSIONS APPROXIMATELY EVERY EIGHT WEEKS, WITH THE MOST RECENT INFUSION PERFORMED ON (b)(6) 2026. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Pain
MAUDE report 25809677 ↗InjuryJul 6, 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 25714067 ↗InjuryJun 26, 2026Device Appears to Trigger Rejection; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2017, A PATIENT UNDERWENT PORT PLACEMENT VIA THE LEFT SUBCLAVIAN VEIN USING A BARD POWERPORT CLEARVUE SLIM IMPLANTABLE PORT FOR CHEMOTHERAPY OF RIGHT LUNG CANCER. APPROXIMATELY THREE MONTHS AND SIXTEEN DAYS LATER, ON (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH FLORID LEFT SIDED DEEP VEIN THROMBOSIS (DVT) AND DEEP VENOUS THROMBOTIC OCCLUSION ASSOCIATED WITH THE LEFT SUBCLAVIAN PORT A CATH. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 25632756 ↗DeathJun 18, 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25542442 ↗MalfunctionJun 5, 2026
SURGICAL TEAM AND SURGEON REPORTED THAT WHILE IMPLANTING THE POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, THE WIRE WOULD NOT ADVANCE THROUGH THE CATHETER. SURGEON CHECKED THE WIRE AWAY FROM PATIENT ALSO WITH NO ADVANCEMENT. NEW POWERPORT OBTAINED AND SURGERY CONTINUED. CATHETER, PACKAGING AND KIT SAVED. POWERPORT CLEARVEW SLIM IMPLANTABLE PORT: BARD, REF# 1616000, LOT#REKX2730, EXP:1/31/2027.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407810 ↗MalfunctionApr 28, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE IN THE LEFT INTERNAL JUGULAR VEIN USING A POWERPORT CLEARVUE SLIM. A CONTRAST ENHANCED CT SCAN WAS PERFORMED ON (B)(6) 2026, WITHOUT ANY COMPLICATIONS. SUBSEQUENTLY, THE PATIENT REPORTED A PRICKLING SENSATION IN THE CHEST AREA, AND THE PORT WAS REMOVED ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25011200 ↗MalfunctionApr 28, 2026Fracture; Deformation Due to Compressive Stress; Naturally Worn
ON (B)(6) 2025, A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE IN THE LEFT INTERNAL JUGULAR VEIN USING A POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE, CRACKS WERE NOTED APPROXIMATELY THREE CM FROM THE PORT HUB. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25011194 ↗MalfunctionApr 20, 2026Difficult to Insert; Nonstandard Device; Deformation Due to Compressive Stress; Material Deformation
ON (B)(6) 2026, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DILATOR FELT ROUGHER THAN USUAL, WHICH PREVENTED FROM INSERTING IT. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24921798 ↗InjuryMar 30, 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 24710706 ↗InjuryMar 2, 2026Expulsion
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE DEVICE WAS ALLEGEDLY ERODED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Skin Erosion; Unspecified Infection
MAUDE report 24480542 ↗InjuryMar 2, 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 BLOOD CLOTS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24480518 ↗MalfunctionFeb 27, 2026Difficult to Flush
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWER PORT CLEARVUE SLIM. DURING THE USE, IT WAS NOTED THAT FLUSHING DID NOT OCCUR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468016 ↗InjuryFeb 24, 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 24426869 ↗MalfunctionFeb 17, 2026Difficult to Flush; Suction Problem
ON (B)(6) 2020, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. POST PROCEDURE, NURSING STAFF WERE UNABLE TO FLUSH THE PORT OR OBTAIN A BLOOD RETURN. THE TREATING PHYSICIAN ORDERED A DYE STUDY TO FURTHER EVALUATE THE FUNCTIONALITY OF THE PORT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361586 ↗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 24321372 ↗InjuryJan 13, 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 24051376 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME LATER POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED PULMONARY EMBOLISM AND SHORTNESS OF BREATH. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Dyspnea; Pulmonary Embolism
MAUDE report 23971115 ↗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 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 23895248 ↗InjuryDec 22, 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 23861672 ↗InjuryDec 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23813763 ↗
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
- 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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