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PowerPort 1709601Recalls & reported problems

Bard Access Systems, Inc. · PowerPort Implantable Port with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs) · Class 2 · Implant

Adverse event reports
7
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741026737), received between Apr 19, 2019 and Jan 4, 2022 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Missing5
  • Defective Component3
  • Difficult to Advance2
  • Material Too Rigid or Stiff2
  • Failure to Advance1

Patient problems

  • No Patient Involvement4
  • Hemothorax2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Consequences Or Impact To Patient1
  • Vascular Dissection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 4, 2022Material Too Rigid or Stiff; Difficult to Advance; Material Too Rigid or Stiff; Difficult to Advance

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DILATOR AND SHEATH WERE ALLEGEDLY STIFFEN. IT WAS FURTHER REPORTED THAT THE CATHETERS WERE NOT ADVANCING OVER THE WIRE SMOOTHLY. REPORTEDLY, PATIENT DEVELOPED A DISSECTION, LEADING TO HEMOTHORAX. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemothorax

    MAUDE report 13154054 ↗
  • InjuryJan 4, 2022Material Too Rigid or Stiff; Failure to Advance; Difficult to Advance; Material Too Rigid or Stiff; Failure to Advance; Difficult to Advance

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE THROUGH THE RIGHT SUBCLAVIAN, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE ADVANCED. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED DISSECTION LEADING TO HEMOTHORAX. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Hemothorax; Vascular Dissection

    MAUDE report 13151087 ↗
  • MalfunctionOct 18, 2019Component Missing; Component Missing

    THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1709601 IMPLANTED PORT ALLEGEDLY EXPERIENCED A COMPONENT MISSING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THESE THREE MALFUNCTIONS DID NOT INVOLVE A PATIENT. THE PATIENT AGE, GENDER, AND WEIGHT WERE NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 9211033 ↗
  • MalfunctionOct 18, 2019Defective Component; Component Missing; Defective Component; Component Missing

    THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1709601. PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY HAD A DEFECTIVE COMPONENT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

    Patient problems: No Patient Involvement

    MAUDE report 9210907 ↗
  • MalfunctionJul 19, 2019Defective Component; Component Missing; Defective Component; Component Missing

    THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE TIP OF THE TUNNELER WAS ALLEGEDLY MISSING FROM A MODEL 1709601 PORT & CATHETER. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 8809003 ↗
  • MalfunctionJul 18, 2019Defective Component; Component Missing; Defective Component; Component Missing

    THIS REPORT SUMMARIZES THREE (3) MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1709601 IMPLANTED PORT ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT AND INCORRECT COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTIONS DID NOT INVOLVE PATIENTS AS THERE WAS NO PATIENT CONTACT. THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 8805470 ↗
  • MalfunctionApr 19, 2019Component Missing; Component Missing

    THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 1709601 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGED DIFFICULTY DURING PORT PLACEMENT BECAUSE THERE WAS AN INCORRECT TUNNELER IN THE KIT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. OF THE ONE EVENT, DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8533127 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

All PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.