PowerPort ClearVUERecalls & reported problems across all models
Bard Access Systems, Inc. · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PowerPort ClearVUE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,993
- Deaths reported
- 77
- Injuries reported
- 1,226
- Recalls
- 15
We found 27 models of PowerPort ClearVUE by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,993 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2016 and Sep 30, 2026 — classified as 77 deaths, 1,226 injuries, 690 malfunctions.
The most frequently reported specific device problem is “Fracture” (292 reports).
15 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PowerPort ClearVUE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 15, 2020Open, Classified
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Z-1964-2020 · Root cause: Employee error · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1773-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1772-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1771-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1770-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1769-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1768-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1767-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1766-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1765-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1764-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1763-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
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 ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1761-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
- Feb 8, 2018Completed
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1760-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported PowerPort ClearVUE problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,002
- Fracture292
- Suction Problem129
- Device Appears to Trigger Rejection117
- Obstruction of Flow108
- Fluid/Blood Leak104
- Material Separation92
- Migration78
Patient problems
- Unspecified Infection728
- No Clinical Signs, Symptoms or Conditions570
- Thrombosis/Thrombus394
- Pain98
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available97
- No Consequences Or Impact To Patient94
- Bacterial Infection90
- Sepsis75
PowerPort ClearVUE models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPort ClearVUE 1608062PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort ClearVUE 1616000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths122 reports
- PowerPort ClearVUE 1618000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 deaths121 reports
- PowerPort ClearVUE 5676300PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 recalls1 death19 reports
- PowerPort ClearVUE 5678300PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 recalls12 reports
- PowerPort ClearVUE 1678301PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 recalls4 reports
- PowerPort ClearVUE 5668362PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall38 reports
- PowerPort ClearVUE 1668362PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall1 death37 reports
- PowerPort ClearVUE 1678300PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall1 death32 reports
- PowerPort ClearVUE 5618000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 deaths75 reports
- PowerPort ClearVUE 1606062PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths73 reports
- PowerPort ClearVUE 1608052PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death73 reports
- PowerPort ClearVUE 1616070PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR66 reports
- PowerPort ClearVUE 1676300PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall16 reports
- PowerPort ClearVUE 5676301PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall1 death12 reports
- PowerPort ClearVUE 1676301PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall5 reports
- PowerPort ClearVUE 1606052PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR54 reports
- PowerPort ClearVUE 5616000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death50 reports
- PowerPort ClearVUE 1666362PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall0 reports
- PowerPort ClearVUE CP00004PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall0 reports
- PowerPort ClearVUE CP00005PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall0 reports
- PowerPort ClearVUE 1618070PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death37 reports
- PowerPort ClearVUE 1618001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths19 reports
- PowerPort ClearVUE 5666362PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR8 reports
- PowerPort ClearVUE 1616001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- PowerPort ClearVUE 1616071PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
Recent PowerPort ClearVUE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Suction Problem; Obstruction of Flow; Blocked Connection
It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned, including failure to access, poor blood return, and inability to draw blood from or flush the port. Additionally, the device allegedly occluded and occlusion treatment was required. However, no patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947213 ↗InjurySep 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 was unknown.
Patient problems: Unspecified Infection
MAUDE report 50945162 ↗InjurySep 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 was unknown.
Patient problems: Unspecified Infection
MAUDE report 50945158 ↗InjurySep 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 was unknown.
Patient problems: Unspecified Infection
MAUDE report 50929876 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929318 ↗InjurySep 29, 2026Material Deformation
It was reported through the litigation process that, sometime after the port placement, the catheter allegedly kinked at the port catheter junction. Additionally, the patient was diagnosed with an unspecified infection. However, the current status of the patient was unknown.
Patient problems: Unspecified Infection
MAUDE report 50929316 ↗InjurySep 29, 2026Fracture; Device Appears to Trigger Rejection; Material Separation; Migration
It was reported through the litigation process that, sometime after the port placement, the catheter tip allegedly retracted and migrated, requiring port exchange or revision. Additionally, a catheter fragment allegedly migrated to the lower right internal jugular vein. Further, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50928874 ↗InjurySep 29, 2026Device Appears to Trigger Rejection; Obstruction of Flow
It was reported through the litigation process that, sometime after the port placement, the catheter, port body, and reservoir allegedly occluded. Additionally, port catheter dysfunction with clotting or occlusion resulted in a nonfunctioning port, and port dysfunction was reported. It was further reported that the patient was diagnosed with thrombosis. The port was subsequently removed. However, the current status of the patient was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50928173 ↗MalfunctionSep 29, 2026Obstruction of Flow
It was reported through the litigation process that, sometime after the port placement, the catheter and port body or reservoir allegedly became occluded. However, there was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927851 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned. It was further reported that contrast extravasation occurred at the port body site with swelling in the surrounding subcutaneous tissue, resulting in a nonfunctional port. Additionally, the patient was diagnosed with bacteremia (bloodstream infection). The port was subsequently removed. However, the current status of the patient was unknown.
Patient problems: Bacteremia; Extravasation; Swelling/ Edema
MAUDE report 50913803 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia; Extravasation; Swelling/ Edema
MAUDE report 50913799 ↗MalfunctionSep 28, 2026Suction Problem; Migration
It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned, with difficulty aspirating from the indwelling port, and the port was reported to have migrated. However, no patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912633 ↗InjurySep 28, 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 50912189 ↗InjurySep 28, 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 50911168 ↗InjurySep 28, 2026Device Appears to Trigger Rejection; Migration
It was reported through the litigation process that, sometime after the port placement, the catheter tip allegedly migrated. Additionally, the patient was diagnosed with thrombosis and pulmonary embolism. However, the current status of the patient is unknown.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 50911166 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
- Navarre Opti-Drain8 models · 1,197 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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