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PowerPort M.R.I., Groshong 1808550Recalls & reported problems

Bard Access Systems, Inc. · PowerPort isp M.R.I. Implantable Port with Suture Plugs with Attachable 8F Groshong Single-Lumen Venous Catheter Peel-Apart Introducer Kit and 5F Microintroducer Kit · Class 2 · Implant

All models of PowerPort M.R.I., Groshong (10)

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

Adverse event reports
18
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741027093), received between Jul 17, 2019 and Aug 11, 2026 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture7
  • Fluid/Blood Leak5
  • Migration5
  • Adverse Event Without Identified Device or Use Problem3
  • Deformation Due to Compressive Stress3
  • Material Separation3
  • Difficult to Flush2
  • Illegible Information2

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • Extravasation4
  • Unspecified Infection4
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
  • Pain3
  • Diarrhea1
  • Embolism/Embolus1
  • Nausea1

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 11, 2026Device Contamination with Chemical or Other Material

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50207116 ↗
  • InjuryAug 5, 2026Fluid/Blood Leak; Fracture; Material Separation; Migration

    On (b)(6) 2025, a patient underwent a port placement procedure using a PowerPort M.R.I. isp. Post the procedure on (b)(6) 2026, the patient reportedly experienced significant bleeding from the device site. Subsequent evaluation, including X-ray imaging, revealed an alleged crack in the port. The procedure was completed using an alternative device. The port was scheduled for explanation; however, the procedure was not performed due to the patient's hospitalization. The removal was subsequently rescheduled for (b)(6) 2026, but the device was again not explanted for unspecified reasons. Following continued concerns regarding the patient's condition and suspected sepsis, the patient was evaluated at the hospital. On (b)(6) 2026, chest X-ray and contrast-enhanced CT imaging reportedly confirmed that the Port-a-Cath catheter had fractured and migrated from its original position into the right atrium, extending into the pulmonary artery. The majority of the fractured catheter was subsequently retrieved via a groin-access procedure. Following the retrieval procedure, the patient was admitted to the Intensive Care Unit (ICU) for three days. Also, the patient experienced not feeling well, se

    Patient problems: Diarrhea; Embolism/Embolus; Nausea; Pain; Sepsis; Vomiting

    MAUDE report 50144338 ↗
  • MalfunctionMay 14, 2026Illegible Information

    A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. IMPLANTABLE PORT. DURING THE PROCEDURE THE PROVIDER EXPERIENCED BRIEF CONFUSION DUE TO CATHETER MARKERS THAT WERE NOT CLEARLY LABELED AND DIFFERED FROM THOSE ON OTHER PORTS. THE EVENT INVOLVED A PATIENT AND RESULTED IN A MILD PROCEDURAL DELAY WHILE THE PROVIDER INTERPRETED THE CATHETER MARKINGS; HOWEVER, THE PROCEDURE CONTINUED WITHOUT INTERRUPTION. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25169630 ↗
  • MalfunctionMay 14, 2026Illegible Information

    A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. IMPLANTABLE PORT. DURING THE PROCEDURE THE PROVIDER EXPERIENCED BRIEF CONFUSION DUE TO CATHETER MARKERS THAT WERE NOT CLEARLY LABELED AND DIFFERED FROM THOSE ON OTHER PORTS. THE EVENT INVOLVED A PATIENT AND RESULTED IN A MILD PROCEDURAL DELAY WHILE THE PROVIDER INTERPRETED THE CATHETER MARKINGS; HOWEVER, THE PROCEDURE CONTINUED WITHOUT INTERRUPTION. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25169462 ↗
  • 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 AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 24964388 ↗
  • InjuryJan 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 PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Pulmonary Embolism

    MAUDE report 24198523 ↗
  • InjuryOct 30, 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. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23422919 ↗
  • InjurySep 29, 2025Fluid/Blood Leak; Difficult to Flush; Fracture; Material Separation; Stretched; Material Protrusion/Extrusion; Migration; Fluid/Blood Leak; Difficult to Flush; Fracture; Material Separation; Stretched; Material Protrusion/Extrusion; Migration

    ON (B)(6) 2022. A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT M.R.I. IMPLANTABLE PORT. SOMETIMES LATER POST PORT PLACEMENT, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY EXPERIENCED ISSUES WITH FLUSHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS FOUND TO BE FRACTURED. REPORTEDLY, THE CATHETER WAS MIGRATED INTO PATIENT'S HEART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

    MAUDE report 23165055 ↗
  • InjurySep 29, 2025Difficult to Flush; Fracture; Device Appears to Trigger Rejection; Material Separation; Suction Problem; Migration; Difficult to Flush; Fracture; Device Appears to Trigger Rejection; Material Separation; Suction Problem; Migration

    ON (B)(6) 2022. A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT M.R.I. IMPLANTABLE PORT. SOMETIMES LATER POST PORT PLACEMENT, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY EXPERIENCED ISSUES WITH FLUSHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS FOUND TO BE FRACTURED. REPORTEDLY, THE CATHETER WAS MIGRATED INTO PATIENT'S HEART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

    MAUDE report 23164871 ↗
  • InjuryFeb 4, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Material Twisted/Bent; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Material Twisted/Bent

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER FRACTURED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21302624 ↗
  • InjuryDec 10, 2024Migration; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY MIGRATED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY DEVELOPED WITH AN INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 20898520 ↗
  • InjuryDec 10, 2024Migration; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY MIGRATED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY DEVELOPED WITH AN INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 20898517 ↗
  • InjuryJul 17, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN. IT WAS FURTHER REPORTED THAT KINK WAS ALLEGEDLY FOUND IN THE PORT CATHETER. FURTHERMORE, ANTIBIOTICS WERE PRESCRIBED FOR CYST AND PUSS FOUND IN THE POCKET OF THE PORT. REPORTEDLY, THE PORT WAS REMOVED. THE PATIENT IS REPORTED TO BE STABLE.

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

    MAUDE report 19758659 ↗
  • InjuryAug 20, 2021Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn

    IT WAS REPORTED THAT DURING THE PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

    MAUDE report 12347259 ↗
  • InjuryAug 20, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THAT DURING THE PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

    MAUDE report 12347222 ↗
  • MalfunctionJun 3, 2021Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

    IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY OCCLUDED AND UNABLE TO WITHDRAW BLOOD. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11929721 ↗
  • MalfunctionMar 15, 2021Fracture; Fracture

    IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT, THE BRACELET ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11479231 ↗
  • MalfunctionJul 17, 2019Component Missing; Component Missing

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1808550 PORT ALLEGEDLY EXPERIENCED A MISSING COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THERE WAS NO REPORTED PATIENT INVOLVEMENT FOR THE MALFUNCTION. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 8800716 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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Sources and updates

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