PowerPort M.R.I., GroshongRecalls & reported problems across all models
Bard Access Systems, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,285
- Deaths reported
- 16
- Injuries reported
- 482
- Recalls
- 0
We found 10 models of PowerPort M.R.I., Groshong by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,285 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2017 and Sep 30, 2026 — classified as 16 deaths, 482 injuries, 787 malfunctions.
The most frequently reported specific device problem is “Fracture” (809 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PowerPort M.R.I., Groshong problems
Device problems
- Fracture809
- Deformation Due to Compressive Stress364
- Fluid/Blood Leak333
- Material Separation304
- Naturally Worn289
- Migration163
- Adverse Event Without Identified Device or Use Problem121
- Suction Problem107
Patient problems
- No Clinical Signs, Symptoms or Conditions636
- No Consequences Or Impact To Patient161
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available154
- Pain78
- Unspecified Infection76
- Thrombosis/Thrombus62
- Extravasation55
- Foreign Body In Patient45
PowerPort M.R.I., Groshong models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPort M.R.I., Groshong 9808560PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort M.R.I., Groshong 1808560PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., Groshong 4808560PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death52 reports
- PowerPort M.R.I., Groshong 1878000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths37 reports
- PowerPort M.R.I., Groshong 1808561PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR21 reports
- PowerPort M.R.I., Groshong 1808550PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 reports
- PowerPort M.R.I., Groshong 1808551PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR7 reports
- PowerPort M.R.I., Groshong 1878001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 reports
- PowerPort M.R.I., Groshong 4808561PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 reports
- PowerPort M.R.I., Groshong 1878070PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
Recent PowerPort M.R.I., Groshong adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
It was reported through the 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 was unknown.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 50946176 ↗MalfunctionSep 24, 2026Fluid/Blood Leak; Difficult to Flush; Suction Problem
A patient underwent a port placement procedure using the PowerPort M.R.I. ISP Port. Sometime after implantation, a nurse observed fluid leaking from the Huber needle puncture site while flushing the port. Aspiration and flushing difficulties were also reported. Further, the port was removed due to suspected CV port occlusion/clogging. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882616 ↗MalfunctionSep 24, 2026Suction Problem; Air/Gas in Device
On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort M.R.I. isp. During the procedure, after confirming blood backflow, the healthcare professional attempted to withdraw the syringe but was unable to do so. A second attempt was made using saline; however, only air could be drawn up, and the saline could not be aspirated. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877871 ↗InjurySep 23, 2026Device Appears to Trigger Rejection; Obstruction of Flow
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis and occlusion. However, the current status of the patient was unknown.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 50868148 ↗InjurySep 23, 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 was unknown.
Patient problems: Pulmonary Embolism
MAUDE report 50868147 ↗DeathAug 27, 2026Fracture
It was reported through the litigation process that, sometime after the port placement, the catheter had allegedly fractured. It was further reported that the patient eventually expired. However, the cause of death was not reported.
Patient problems: Insufficient Information
MAUDE report 50471316 ↗InjuryAug 17, 2026Device Appears to Trigger Rejection
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. However, the current status of the patient remains unknown
Patient problems: Thrombosis/Thrombus
MAUDE report 50270100 ↗MalfunctionAug 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252177 ↗MalfunctionAug 14, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251847 ↗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 ↗InjuryAug 5, 2026Difficult to Flush; Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method; Obstruction of Flow
On (b)(6) 2026, a patient underwent a port placement procedure using a PowerPort M.R.I. isp. On (b)(6) 2026, during an outpatient visit, the port was accessed; however, medication could not be infused through the device. The port was subsequently removed, and a blood like substance was observed adherent near the valve slit at the catheter tip. Following transection of the catheter tip, patency was restored and normal flow was confirmed by flushing the port with normal saline. The obstruction was determined to be due to a clog at the catheter tip. It was reported that blood resembling a clot was adhering to the slit in the catheter valve at the time of removal. The device was retrieved for evaluation. The current status of the patient is unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50144335 ↗InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25777051 ↗MalfunctionJul 10, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25776053 ↗DeathJul 3, 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 AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25701604 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- Navarre15 models · 1,228 reports
- Navarre Opti-Drain8 models · 1,197 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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