PowerPort M.R.I.Recalls & reported problems across all models
Bard Access Systems, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 264
- Deaths reported
- 7
- Injuries reported
- 175
- Recalls
- 0
We found 8 models of PowerPort M.R.I. by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 264 adverse event reports in the FDA's MAUDE database, received between May 2, 2018 and Sep 29, 2026 — classified as 7 deaths, 175 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Fracture” (68 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. problems
Device problems
- Adverse Event Without Identified Device or Use Problem124
- Fracture68
- Material Separation33
- Migration22
- Component Missing21
- Obstruction of Flow14
- Defective Component13
- Fluid/Blood Leak11
Patient problems
- Unspecified Infection92
- Thrombosis/Thrombus71
- No Clinical Signs, Symptoms or Conditions55
- No Consequences Or Impact To Patient22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available21
- No Patient Involvement12
- Pain12
- Sepsis11
PowerPort M.R.I. models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPort M.R.I. 1809600PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death72 reports
- PowerPort M.R.I. 1809660PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death51 reports
- PowerPort M.R.I. 1859660PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death45 reports
- PowerPort M.R.I. 1859600PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death42 reports
- PowerPort M.R.I. 1809601PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths20 reports
- PowerPort M.R.I. 1809661PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death14 reports
- PowerPort M.R.I. 1859601PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR11 reports
- PowerPort M.R.I. 1859661PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR9 reports
Recent PowerPort M.R.I. adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 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. However, the current status of the patient was unknown.
Patient problems: Unspecified Infection
MAUDE report 50928171 ↗DeathSep 25, 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 50894474 ↗DeathSep 16, 2026Device Appears to Trigger Rejection
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. It was further reported that the patient eventually expired. However, the cause of death was not reported.
Patient problems: Thrombosis/Thrombus
MAUDE report 50787119 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported through the litigation process that, on (b)(6) 2014, a patient underwent port placement via the right internal jugular vein for the treatment of B cell lymphoma. Approximately two days later, on (b)(6) 2014, the patient experienced bruising at the port site. Additionally, approximately two days later, on (b)(6) 2014, hematoma was observed around the insertion site. Subsequently, the port was removed on (b)(6) 2015. However, the current status of the patient remains unknown.
Patient problems: Bruise/Contusion; Hematoma
MAUDE report 50067080 ↗InjuryJul 27, 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. However, the current status of the patient was unknown.
Patient problems: Unspecified Infection
MAUDE report 50032303 ↗InjuryJul 3, 2026Device Appears to Trigger Rejection; Obstruction of Flow; Material Protrusion/Extrusion; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER AND PORT BODY AND RESERVOIR ALLEGEDLY BECAME OCCLUDED. ADDITIONALLY, PROTRUSION AND MIGRATION WERE OBSERVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 25700990 ↗InjuryJun 29, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25650929 ↗InjuryJun 15, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25499254 ↗InjuryMay 28, 2026Expulsion
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND EROSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Skin Erosion; Unspecified Infection
MAUDE report 25311830 ↗InjuryMay 27, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25296432 ↗MalfunctionMay 25, 2026Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT A CATH ALLEGEDLY DID NOT FUNCTION PROPERLY. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25269175 ↗MalfunctionMay 13, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158718 ↗InjuryMay 12, 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 25146997 ↗InjuryApr 29, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25026793 ↗InjuryApr 29, 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 AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 25024532 ↗
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
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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