PowerPort 1718001Recalls & reported problems
Bard Access Systems, Inc. · PowerPort Slim Implantable Port with Attachable 8 F Polyurethane Open-Ended Single-Lumen Venous Catheter Intermediate Kit (Without Suture Plugs) · Class 2 · Implant
All models of PowerPort (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741026799), received between Oct 7, 2024 and Aug 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Material Separation1
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging
ON (B)(6) 2025, A PATIENT UNDERWENT FOR THE PORT PLACEMENT USING POWERPORT SLIM. IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE THE INTERNAL PEEL ALLEGEDLY FOUND EXTERNAL LAYER RENDERING IT NON-STERILE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805049 ↗MalfunctionOct 7, 2024Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE IN THE RIGHT SUBCLAVIAN VEIN, THE AIR GUARD VALVE ALLEGEDLY TORE WHEN THE SHEATH WAS PULLED APART. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALREADY PASSED THROUGH THE INTRODUCER AND PROCEEDED WITH THE PROCEDURE WITH INCREASED BACK BLEEDING FROM THE VESSEL. FURTHERMORE, THERE IS NO INFORMATION REGARDING ADDITIONAL INTERVENTION NOR MEDICATIONS PRESCRIBED TO TREAT BACK BLEEDING FROM THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20381733 ↗
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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