X-Port isp M.R.I., GroshongRecalls & reported problems across all models
Bard Access Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 172
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls
- 0
We found 2 models of X-Port isp M.R.I., Groshong by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 172 adverse event reports in the FDA's MAUDE database, received between May 9, 2018 and May 27, 2026 — classified as 69 injuries, 103 malfunctions.
The most frequently reported specific device problem is “Fracture” (116 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., Groshong problems
Device problems
- Fracture116
- Material Separation67
- Deformation Due to Compressive Stress46
- Migration41
- Naturally Worn41
- Fluid/Blood Leak32
- Break12
- Difficult to Flush12
Patient problems
- No Clinical Signs, Symptoms or Conditions78
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available32
- No Consequences Or Impact To Patient22
- Pain11
- Swelling/ Edema10
- Extravasation9
- Embolism/Embolus6
- Foreign Body In Patient6
X-Port isp M.R.I., Groshong 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., Groshong 7707540PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR169 reports
- X-Port isp M.R.I., Groshong 7757540PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
Recent X-Port isp 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.
InjuryMay 27, 2026Fracture; Material Separation; Migration
ON (B)(6) 2024, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE VIA RIGHT INTERNAL JUGULAR VEIN USING THE X PORT ISP M.R.I. AFTER SOME TIME, ON (B)(6) 2026, X RAY REVEALED THAT THE CATHETER HAD FRACTURED AND MIGRATED TOWARD THE LEFT PULMONARY ARTERY. IT WAS ALSO REPORTED THAT THE CATHETER HAD EMBOLIZED WITHIN THE PATIENT'S VASCULATURE. THE CATHETER WAS SUBSEQUENTLY REMOVED ON (B)(6) 2026. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Embolism/Embolus
MAUDE report 25296824 ↗MalfunctionApr 22, 2026Difficult to Flush; Reflux within Device; Suction Problem; Device Tipped Over; Deformation Due to Compressive Stress
ON (B)(6) 2025, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE XPORT ISP M.R.I. 1 MONTHS AND 18 DAYS POST PROCEDURE, IT WAS NOTED THAT THE PORT STEM HAD ROTATED FROM THE CEPHALIC SIDE TO THE CAUDAL SIDE. IT WAS ALSO REPORTED THAT THERE WERE BLOOD BACKFLOW AND AN INABILITY TO INFUSE. THE PORT WAS REMOVED ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24951275 ↗InjuryMar 12, 2026Fracture; Material Separation; Migration
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X PORT ISP M.R.I. POST PROCEDURE, ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER HAD COMPLETELY BROKEN AND MIGRATED. ADDITIONALLY, THE PATIENT HAD SWELLING IN THE NECK. THE CATHETER WAS REMOVED ON THE SAME DAY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Swelling/ Edema
MAUDE report 24579999 ↗MalfunctionMar 10, 2026Fracture; Dull, Blunt
ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SHEATH HAD TEAR BEFORE INSERTING AND THE NEEDLE WAS BLUNT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24556736 ↗InjuryMar 10, 2026Difficult to Flush; Fracture; Material Separation; Migration
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X PORT ISP M.R.I. POST PROCEDURE, IT WAS NOTED THAT THE CATHETER HAD COMPLETELY BROKEN AND MIGRATED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SWELLING AND ALSO COULD NOT BE FLUSHED. THE CATHETER AND THE PORT WERE REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Swelling/ Edema
MAUDE report 24555327 ↗InjuryMar 10, 2026Difficult to Flush; Fracture; Material Separation; Migration
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X PORT ISP M.R.I. POST PROCEDURE, ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER HAD COMPLETELY BROKEN AND MIGRATED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SWELLING AND ALSO COULD NOT BE FLUSHED. THE CATHETER AND THE PORT WERE REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Swelling/ Edema
MAUDE report 24555316 ↗InjuryFeb 27, 2026Fluid/Blood Leak; Fracture
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP M.R.I. POST THE PROCEDURE ON (B)(6) 2026, IT WAS FOUND THAT THERE WAS SWELLING IN THE NECK. ALSO, LEAKAGE OF FLUID OBSERVED WHILE PORT WAS FLUSHED. AND X RAY CONFIRMED THAT THE CATHETER ALLEGEDLY FRACTURED IN THE NECK REGION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Swelling/ Edema
MAUDE report 24468078 ↗MalfunctionFeb 12, 2026Component Missing; Component Misassembled
ON (B)(6) 2026, A PATIENT UNDERWENT FOR PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F. IT WAS REPORTED THAT DURING A PROCEDURE, WHEN ATTEMPTING TO USE THE NONCORE NEEDLE INCLUDED IN THE KIT, THE CLINICIAN DISCOVERED THAT THE PACKAGE CONTAINED TWO ANGLED NEEDLES AND NO STRAIGHT NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320768 ↗MalfunctionFeb 4, 2026Failure to Advance; Premature Separation
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP M.R.I. DURING THE PROCEDURE, THE CATHETER DID NOT GLIDE THROUGH THE SHEATH AND FURTHER REPORTED THAT THE SHEATH WAS PARTIALLY PEELED APART DURING INSERTION THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256714 ↗InjuryJan 30, 2026Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration
ON (B)(6) 2024, A 57-YEAR-OLD FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP M.R.I. POST THE PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT PRIOR TO INITIATING CHEMOTHERAPY, AN X-RAY WAS TAKEN AND REVEALED THAT THE CATHETER WAS BROKEN AND HAD MIGRATED INTO THE RIGHT ATRIUM. REPORTEDLY, THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24219665 ↗MalfunctionJan 30, 2026Reflux within Device
ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F. DURING THE PROCEDURE, UNWANTED BLOOD FLOW IS SEEN/ OCCURRED WITHOUT THE ASPIRATION THAT IS BACKFLOW. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219100 ↗MalfunctionJan 12, 2026Fracture; Material Separation
ON (B)(6) 2017, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F. A PORT WAS IMPLANTED AND USED MULTIPLE TIMES FOR CHEMOTHERAPY. POST THE PROCEDURE ON (B)(6) 2025, THE PORT WAS REMOVED, AND CATHETER DISCONNECTION WAS CONFIRMED DURING REMOVAL. HOWEVER, THE CATHETER TIP AND ENDPOINT COULD NOT BE RETRIEVED. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034031 ↗InjuryDec 23, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP M.R.I. POST THE PROCEDURE ON (B)(6) 2025, THE PORT ALLEGEDLY LEAKED, AND IT WAS NOTED THAT THE PATIENT EXPERIENCED REDNESS AND BLEEDING OCCURRED AROUND THE PORT. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23875286 ↗MalfunctionDec 22, 2025Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn
ON (B)(6) 2024, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT. POST THE PROCEDURE ON (B)(6) 2025, THE CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861438 ↗InjuryDec 19, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration
A PATIENT UNDERWENT FOR PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F. DURING AN X-RAY EXAMINATION, IT WAS REPORTED THAT AFTER PORT IMPLANTATION, THE PHYSICIAN IDENTIFIED THAT THE CATHETER WAS ALLEGEDLY BROKEN, WITH HALF OF THE BROKEN SEGMENT LOCATED IN THE RIGHT ATRIUM (RA). THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23847732 ↗
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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