PowerPort M.R.I., Groshong 1878001Recalls & reported problems
Bard Access Systems, Inc. · PowerPort M.R.I. Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter. Intermediate Kit (without Suture Plugs) · 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741027253), received between Aug 31, 2020 and Dec 13, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
Most reported problems
Device problems
- Fracture3
- Material Separation3
- Migration3
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Material Twisted/Bent1
- Migration or Expulsion of Device1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Burning Sensation1
- Chest Pain1
- Embolism/Embolus1
- Hemoptysis1
- Injury1
- Itching Sensation1
- Myocardial Infarction1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION AND STROKE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Stroke/CVA; Unspecified Infection
MAUDE report 23797152 ↗InjuryApr 29, 2024Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT A PORT WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH BREAST CANCER. IT WAS FURTHER REPORTED THAT ONE YEAR, FOUR MONTHS AND FIVE DAYS POST A PORT PLACEMENT VIA THE RIGHT JUGULAR VEIN APPROACH, THE CATHETER WAS ALLEGEDLY FRACTURED AT THE PROXIMAL ONE BY THIRD LEVEL AND THE DISTAL TWO THIRD OF THE CATHETER WAS ALLEGEDLY VISUALIZED IN THE RIGHT HEART. FURTHERMORE, THE PATIENT UNDERWENT ATTEMPTED REMOVAL OF FOREIGN OBJECT AND THE LONGER SHEATH WAS ADVANCED THE SNARE UNDER FLUOROSCOPY GUIDANCE MODERATELY ATTEMPT TO SNARE THE CATHETER WAS UNSUCCESSFUL. PATIENT WAS REFERRED TO SURGERY. PATIENT UNDERWENT REMOVAL OF PORT AND REMOVAL OF INTRACARDIAC FOREIGN BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19199425 ↗InjuryApr 4, 2024Fracture; Material Separation; Material Twisted/Bent; Migration; Fracture; Material Separation; Material Twisted/Bent; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE AND THE DISTAL CATHETER FRAGMENT ALLEGEDLY COILED. IT WAS FURTHER REPORTED THAT THE DISLODGED CATHETER WAS IN RIGHT ATRIUM. FURTHERMORE, THE PATIENT ALLEGEDLY DEVELOPED PULMONARY EMBOLISM AND MYOCARDIAL INFARCTION. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Myocardial Infarction; Pulmonary Embolism
MAUDE report 19039906 ↗InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO DAYS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED RASHES. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED ITCHING. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Itching Sensation; Rash
MAUDE report 17265825 ↗InjuryAug 31, 2020Fracture; Migration or Expulsion of Device; Material Separation; Device Dislodged or Dislocated; Migration; Fracture; Migration or Expulsion of Device; Material Separation; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT AFTER PORT PLACEMENT, THE CATHETER ALLEGEDLY DISLODGED FROM THE PORT AND MIGRATED TO THE HEART. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED HEART ATTACK AND UNDERWENT SURGERY. THE PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Embolism/Embolus; Hemoptysis; Injury
MAUDE report 10470589 ↗
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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