PowerPortRecalls & reported problems across all models
Bard Access Systems, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 138
- Deaths reported
- 3
- Injuries reported
- 78
- Recalls
- 0
We found 13 models of PowerPort by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 138 adverse event reports in the FDA's MAUDE database, received between May 17, 2018 and Sep 28, 2026 — classified as 3 deaths, 78 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Fracture” (33 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. 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
Most reported PowerPort problems
Device problems
- Adverse Event Without Identified Device or Use Problem54
- Fracture33
- Migration15
- Material Separation11
- Suction Problem9
- Deformation Due to Compressive Stress7
- Fluid/Blood Leak7
- Obstruction of Flow6
Patient problems
- Unspecified Infection46
- No Clinical Signs, Symptoms or Conditions40
- Thrombosis/Thrombus21
- No Consequences Or Impact To Patient12
- Pain10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- No Patient Involvement6
- Pulmonary Embolism4
PowerPort models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPort CP00003PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death46 reports
- PowerPort 1716070PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR21 reports
- PowerPort 1708160PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR12 reports
- PowerPort 1759600PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR11 reports
- PowerPort CP00002PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death11 reports
- PowerPort 1709600PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR8 reports
- PowerPort 1709601PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR7 reports
- PowerPort 1718000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR7 reports
- PowerPort 1716071PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 reports
- PowerPort 1759601PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death4 reports
- PowerPort 1706062PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- PowerPort 1718001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- PowerPort CP00001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
Recent PowerPort adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 50911170 ↗MalfunctionSep 23, 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 50866598 ↗MalfunctionSep 23, 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 50866597 ↗MalfunctionSep 23, 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 50864179 ↗InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported through litigation process that sometime later post port placement procedure via the right jugular vein, the patient was diagnosed with an unspecified infection. However, the current status of the patient is unknown.
Patient problems: Unspecified Infection
MAUDE report 50190900 ↗InjuryAug 3, 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 50112310 ↗MalfunctionJun 22, 2026Device Tipped Over; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY FLIPPED, RESULTING IN PORT DYSFUNCTION. ADDITIONALLY, THE PORT BODY WAS FLIPPED, AND A FRAGMENT MIGRATED, WITH THE CATHETER TIP PULLED BACK FROM THE CAVOATRIAL JUNCTION. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25573583 ↗DeathJun 4, 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.
Patient problems: Unspecified Infection
MAUDE report 25392306 ↗MalfunctionMay 28, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT ALLEGEDLY HAD CATHETER FRACTURE. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25312109 ↗MalfunctionMay 25, 2026Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT ALLEGEDLY MIGRATED AND MALFUNCTIONED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267796 ↗InjuryApr 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 IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25024795 ↗InjuryApr 23, 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 24965404 ↗MalfunctionApr 21, 2026Unsealed Device Packaging
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWERPORT SLIM IMPLANTABLE PORT. DURING INSPECTION OF THE DEVICE, THE OUTER STERILE PACKAGE WAS FOUND TO BE INCOMPLETELY SEALED. THE INNER STERILE BARRIER REMAINED INTACT, AND THE CUSTOMER DETERMINED THAT STERILITY WAS NOT COMPROMISED. THE DEVICE WAS SUBSEQUENTLY USED, AS THE INTERNAL PACKAGING WAS UNDAMAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938584 ↗MalfunctionMar 26, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696879 ↗InjuryMar 23, 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 24660071 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- 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
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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