BardPort M.R.I., GroshongRecalls & reported problems across all models
Bard Access Systems, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 253
- Deaths reported
- 2
- Injuries reported
- 97
- Recalls
- 0
We found 7 models of BardPort M.R.I., Groshong by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 253 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2016 and Sep 24, 2026 — classified as 2 deaths, 97 injuries, 154 malfunctions.
The most frequently reported specific device problem is “Fracture” (133 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 BardPort M.R.I., Groshong problems
Device problems
- Fracture133
- Material Separation66
- Fluid/Blood Leak45
- Migration40
- Deformation Due to Compressive Stress39
- Break36
- Naturally Worn21
- Adverse Event Without Identified Device or Use Problem17
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- No Consequences Or Impact To Patient54
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available38
- Unspecified Infection15
- Pain14
- Foreign Body In Patient13
- No Patient Involvement12
- Extravasation10
BardPort M.R.I., Groshong models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BardPort M.R.I., Groshong 0602830PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death108 reports
- BardPort M.R.I., Groshong 0602833PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR88 reports
- BardPort M.R.I., Groshong 0603870PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death33 reports
- BardPort M.R.I., Groshong 0604520PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 reports
- BardPort M.R.I., Groshong 0605920PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- BardPort M.R.I., Groshong 0602840PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- BardPort M.R.I., Groshong 0603830PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent BardPort 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.
MalfunctionSep 24, 2026Fracture
On (b)(6) 2026, a patient underwent a port placement procedure using the M.R.I. Implantable Port. During the procedure, the catheter fractured while being inserted through the introducer sheath. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877976 ↗InjuryAug 6, 2026Burst Container or Vessel; Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn
A patient underwent a port placement procedure using an M.R.I. Implantable Port. Post procedure on (b)(6)2026, swelling was noted around the port during medication administration and was suspected to be due to subcutaneous leakage. Following X ray evaluation and other diagnostic testing, the port was removed, and a catheter fracture was identified. The current status of the patient was unknown.
Patient problems: Extravasation; Swelling/ Edema
MAUDE report 50152624 ↗InjuryAug 5, 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 was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50144045 ↗MalfunctionJul 3, 2026Reflux within Device; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PORT PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN USING AN M.R.I. IMPLANTABLE PORT. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO INSERT THE GUIDEWIRE DUE TO THE UNSUITABLE SHAPE OF THE WIRES SHEATH, WHICH HINDERED THUMB ASSISTED INSERTION AND MADE IT CHALLENGING TO OVERCOME THE NATURAL BEND AT THE TIP. THIS LED TO PROCEDURAL DIFFICULTY AND INCREASED TENSION, AS THE DILATOR WAS POSITIONED IN THE VEIN, RESULTING IN UNDESIRABLE BLOOD REFLUX. WITH SIGNIFICANT EFFORT, THE GUIDEWIRE WAS EVENTUALLY INSERTED BUT BECAME DIFFICULT TO ADVANCE WITHOUT AN APPARENT CAUSE, REQUIRING FORCEFUL MANIPULATION. ALTHOUGH ADVANCEMENT WAS ACHIEVED, RETRIEVAL OF THE GUIDEWIRE WAS NOT POSSIBLE, AS NO SEGMENT WAS ACCESSIBLE FOR WITHDRAWAL. FLUOROSCOPY REVEALED THAT THE GUIDEWIRE WAS POSITIONED UNSTABLY AT THE TIP, POSING A HIGH RISK OF DETACHMENT AND POTENTIAL EMBOLISM. THE ENTIRE SYSTEM WAS CAREFULLY RETRACTED UNDER DYNAMIC FLUOROSCOPY WITHOUT WIRE DETACHMENT; HOWEVER, THE GUIDEWIRE KINKED, RENDERING THE PORT IMPLANTATION UNSUCCESSFUL. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703985 ↗DeathJun 26, 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 25635197 ↗InjuryJun 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25592796 ↗MalfunctionMay 4, 2026Failure to Advance; Deformation Due to Compressive Stress
THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. PORT. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER COULD NOT BE ADVANCED DUE TO THE INNER TUBE OF THE SHEATH BEING CRUSHED AT MULTIPLE LOCATIONS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25065028 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported through the litigation process that, sometime after the port placement procedure, a port malfunction occurred, and the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.
Patient problems: Unspecified Infection
MAUDE report 24685693 ↗MalfunctionMar 23, 2026Fracture; Material Separation; Material Protrusion/Extrusion
ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. PORT. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE RESERVOIR CHAMBER HAD COMPLETELY BROKEN OFF FROM THE PORT AND THE RESERVOIR ALSO DISLODGED FROM THE PORT SEPTUM. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, SO THE CATHETER WAS REMOVED. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: Discomfort
MAUDE report 24659622 ↗InjuryMar 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24659465 ↗InjuryMar 19, 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 24637491 ↗InjuryMar 16, 2026Fracture; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Obstruction/Occlusion
MAUDE report 24602919 ↗MalfunctionMar 5, 2026Fracture
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24519362 ↗InjuryFeb 26, 2026Fracture; Material Separation; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED AND MIGRATED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24451410 ↗MalfunctionFeb 18, 2026Insufficient Device Problem Information
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT HAD ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377619 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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