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
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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- 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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