X-Port isp M.R.I., ChronoFlexRecalls & reported problems across all models
Bard Access Systems, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 1
- Injuries reported
- 27
- Recalls
- 0
We found 3 models of X-Port isp M.R.I., ChronoFlex by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2015 and Sep 29, 2026 — classified as 1 death, 27 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 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 X-Port isp M.R.I., ChronoFlex problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Fracture10
- Deformation Due to Compressive Stress8
- Obstruction of Flow7
- Fluid/Blood Leak5
- Blocked Connection4
- Difficult to Flush4
- Difficult to Insert4
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Unspecified Infection11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- No Consequences Or Impact To Patient6
- Thrombosis/Thrombus6
- Bacterial Infection3
- Extravasation2
- Sepsis2
X-Port isp M.R.I., ChronoFlex models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- X-Port isp M.R.I., ChronoFlex 0607540PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death53 reports
- X-Port isp M.R.I., ChronoFlex 0607510PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- X-Port isp M.R.I., ChronoFlex 0607500PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent X-Port isp M.R.I., ChronoFlex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 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 50928170 ↗InjuryJun 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25618630 ↗InjuryJun 2, 2026Difficult to Flush; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT COULD NOT BE FLUSHED AND WAS REPORTED TO BE CLOGGED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Obstruction/Occlusion
MAUDE report 25357923 ↗InjuryApr 14, 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 REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24868334 ↗MalfunctionMar 16, 2026Fluid/Blood Leak; Fitting Problem
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE BY USING X PORT MRI ISP. DURING PROCEDURE, IT WAS REPORTED THAT LEAKAGE WAS OBSERVED AT THE CONNECTION POINT OF THE DEVICE. ADDITIONALLY, THE ASSOCIATED TUBING DID NOT FIT PROPERLY INTO THE PORT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603019 ↗MalfunctionMar 12, 2026Fluid/Blood Leak
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X PORT ISP M.R.I. POST PROCEDURE, ON (B)(6) 2026, THE U CATHETER IN THE NECK ALLEGEDLY GOT LEAKED. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577326 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER ALLEGEDLY FRACTURED. THERE WERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23971606 ↗MalfunctionDec 26, 2025Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894832 ↗InjuryNov 27, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY KINKED OFF. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND VENOUS STENOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Stenosis; Unspecified Infection
MAUDE report 23663539 ↗InjuryNov 21, 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 23614912 ↗InjuryOct 27, 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 WAS DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23388873 ↗InjuryOct 16, 2025Fluid/Blood Leak; Material Puncture/Hole; Blocked Connection; Fluid/Blood Leak; Material Puncture/Hole; Blocked Connection
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F. POST THE PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND AN EXTRAVASATION OF CONTRAST. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND POROSITY. REPORTEDLY, THE PORT DOES NOT ALLOW THE TREATMENT TO PASS THROUGH THE CATHETER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Extravasation
MAUDE report 23308065 ↗InjuryOct 16, 2025Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING AN X-PORT ISP IMPLANTABLE PORT. IT WAS REPORTED THAT DURING CHEMOTHERAPY, THE PORT BECAME BLOCKED. SUBSEQUENTLY, THE PORT WAS REMOVED FROM THE PATIENT IN A MINOR OPERATING THEATRE. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23307416 ↗InjuryOct 16, 2025Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING AN X-PORT ISP IMPLANTABLE PORT. 4 MONTHS, 2 DAYS POST THE PROCEDURE, DURING THE THIRD CYCLE OF CHEMOTHERAPY, THE PORT BECAME BLOCKED. SUBSEQUENTLY, ON (B)(6) 2025, THE PORT WAS REMOVED FROM THE PATIENT IN A MINOR OPERATING THEATRE. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23307410 ↗InjuryOct 15, 2025Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING AN X-PORT ISP IMPLANTABLE PORT. IT WAS REPORTED THAT DURING THE CHEMOTHERAPY, THE PORT BECAME BLOCKED. SUBSEQUENTLY, THE PORT WAS REMOVED FROM THE PATIENT IN A MINOR OPERATING THEATRE. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23297442 ↗
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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