X-Port isp M.R.I.Recalls & reported problems across all models
Bard Access Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 2 models of X-Port isp M.R.I. by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2019 and Nov 4, 2025 — classified as 12 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (20 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. problems
Device problems
- Fracture20
- Material Separation11
- Adverse Event Without Identified Device or Use Problem7
- Migration4
- Device Damaged Prior to Use2
- Material Integrity Problem2
- Blocked Connection1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Thrombosis/Thrombus5
- Unspecified Infection3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Pneumothorax2
- Pulmonary Embolism2
- Bacteremia1
- Bacterial Infection1
X-Port isp M.R.I. models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- X-Port isp M.R.I. 0607555PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR26 reports
- X-Port isp M.R.I. 0607550PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 reports
Recent X-Port isp 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.
InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, FIVE MONTHS AND FIFTEEN DAYS POST A PORT PLACEMENT PROCEDURE VIA THE RIGHT SUBCLAVIAN VEIN FOR LONG TERM TOTAL PARENTERAL NUTRITION, THE PATIENT WAS POSITIVE FOR BACTEREMIA. REPORTEDLY, THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacteremia
MAUDE report 23464329 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY FOUR MONTHS THREE WEEKS AND FOUR DAYS LATER PORT PLACEMENT PROCEDURE VIA THE LEFT SUBCLAVIAN VEIN FOR LONG TERM TOTAL PARENTERAL NUTRITION, THE PATIENT DEVELOPED WITH STAPHYLOCOCCUS EPIDERMIS INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED AND A NEW PORT WAS IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection
MAUDE report 23450662 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY FOUR MONTHS ONE WEEK AND TWO DAYS LATER PORT PLACEMENT PROCEDURE VIA THE RIGHT SUBCLAVIAN VEIN FOR LONG TERM TOTAL PARENTERAL NUTRITION, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED AND WAS REPLACED WITH A NEW DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23450507 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE ON (B)(6) 2010, VIA THE RIGHT SUBCLAVIAN VEIN DUE TO THE NEED FOR LONG TERM TOTAL PARENTERAL NUTRITION. APPROXIMATELY FOUR MONTHS AND TWENTY THREE DAYS LATER, ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. THE PORT WAS SUBSEQUENTLY REMOVED, AND A NEW PORT WAS IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23450356 ↗MalfunctionSep 25, 2025Material Puncture/Hole; Material Puncture/Hole
ON (B)(6) 2025, A PATIENT WAS UNDERGOING A PORT PLACEMENT PROCEDURE, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT A SMALL HOLE WAS IDENTIFIED IN THE CATHETER BODY, PREVENTING ITS USE IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23140347 ↗MalfunctionSep 15, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP M.R.I. DURING THE PROCEDURE IT WAS NOTED THAT THE INTRODUCER WAS DEFECTIVE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23049095 ↗InjuryAug 25, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY REPORTED WITH OCCLUSION AND PATIENT DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 22882338 ↗MalfunctionMay 20, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT. DURING A PORT PLACEMENT PROCEDURE, THE HEALTHCARE PROFESSIONAL WAS TRYING TO ACCESS VEIN WITH PUNCTURE NEEDLE. THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22051793 ↗InjuryMay 20, 2025Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22050137 ↗MalfunctionMay 20, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT. DURING A PORT PLACEMENT PROCEDURE, THE HEALTHCARE PROFESSIONAL WAS TRYING TO ACCESS VEIN WITH PUNCTURE NEEDLE. THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049896 ↗MalfunctionMay 20, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT. DURING A PORT PLACEMENT PROCEDURE, THE HEALTHCARE PROFESSIONAL WAS TRYING TO ACCESS VEIN WITH PUNCTURE NEEDLE. THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049895 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 21907129 ↗MalfunctionApr 16, 2025Fracture; Material Separation; Device Damaged Prior to Use; Fracture; Material Separation; Device Damaged Prior to Use
IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE KNOB OF THE PORT ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21851498 ↗MalfunctionJan 21, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE HUB WAS ALLEGEDLY FOUND BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21195830 ↗InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 21089290 ↗
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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