Skip to content

PowerPort, Groshong 1708560Recalls & reported problems

Bard Access Systems, Inc. · PowerPort isp Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs) · Class 2 · Implant

All models of PowerPort, Groshong (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741026706), received between Jul 11, 2019 and Jul 20, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (4 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture4
  • Adverse Event Without Identified Device or Use Problem3
  • Expulsion1
  • Material Separation1
  • Migration1
  • Suction Problem1

Patient problems

  • Injury3
  • Unspecified Infection2
  • Erythema1
  • Itching Sensation1
  • Rash1
  • Skin Erosion1
  • Swelling1
  • Thrombosis/Thrombus1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP. POST PROCEDURE, THE PATIENT REPORTEDLY DEVELOPED REDNESS AND TENDERNESS AT THE PORT SITE. ADDITIONALLY, THE PATIENT EXPERIENCED AN ITCHY RASH ON THE NECK. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Patient problems: Erythema; Itching Sensation; Rash

    MAUDE report 25869653 ↗
  • InjuryDec 18, 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23836106 ↗
  • InjuryOct 21, 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. REPORTEDLY THE PATIENT WAS EXPIRED, AND THE CAUSE OF DEATH WAS NOT PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 23345423 ↗
  • InjuryMay 5, 2025Fracture; Material Separation; Expulsion; Migration; Fracture; Material Separation; Expulsion; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY ERODED, AND THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Skin Erosion; Unspecified Infection

    MAUDE report 21961868 ↗
  • InjuryMar 25, 2020Fracture; Fracture

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR SEVEN MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.

    Patient problems: Injury

    MAUDE report 9878245 ↗
  • InjuryMar 25, 2020Fracture; Fracture

    IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.

    Patient problems: Injury

    MAUDE report 9878242 ↗
  • InjuryMar 25, 2020Fracture; Fracture

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR TWO MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.

    Patient problems: Injury

    MAUDE report 9878122 ↗
  • InjuryJul 11, 2019Suction Problem; Suction Problem

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER THE PLACEMENT OF THE PORT DEVICE, IT WAS ALLEGEDLY UNABLE TO BE ASPIRATED. REPORTEDLY, THE HEALTH CARE PROVIDER WAS ABLE TO ASPIRATE SUCCESSFULLY AFTER THE ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR (TPA). IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AN ALLEGED SWELLING OF THE LEFT ARM. REPORTEDLY, ON DYE STUDY FOUND THAT THE TIP OF THE PORT CATHETER WAS SLIGHTLY RETRACTED NEAR THE JUNCTION OF THE BRACHIOCEPHALIC VEINS WITHOUT EXTRAVASATION. IT WAS FURTHER REPORTED THAT AN ALLEGED THROMBUS WAS IDENTIFIED IN THE SUPERIOR VENA CAVA, LEFT BRACHIOCEPHALIC VEIN, SUBCLAVIAN VEIN AND PROXIMAL ASPECT OF THE CEPHALIC VEIN. REPORTEDLY, AN ADDITIONAL INTERVENTION WAS REQUIRED FOR THROMBUS FORMATION AND PREVENTION, HOWEVER, THE PATIENT WAS REPORTEDLY STABLE.

    Patient problems: Swelling; Thrombus

    MAUDE report 8781678 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page