X-Port isp M.R.I., Groshong 7707540Recalls & reported problems
Bard Access Systems, Inc. · X-Port isp M.R.I. Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter Intermediate Kit · Class 2 · Implant
All models of X-Port isp M.R.I., Groshong (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard X-Port isp M.R.I. implantable port with a Groshong catheter is placed under the skin to give medicines or fluids into a vein. Of its 172 reports, 69 are filed as injuries, and many describe catheter fractures and breaks, with pieces migrating toward the heart or lungs. Others describe blood leaks and cracked connectors. The reports mention no deaths, and no recalls name this device. Reports fell over the past 12 months, with 21 compared with 43 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 169
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00801741027499), received between May 9, 2018 and May 27, 2026 — classified as 68 injuries, 101 malfunctions.
The most frequently reported specific device problem is “Fracture” (115 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture115
- Material Separation67
- Deformation Due to Compressive Stress46
- Migration41
- Naturally Worn41
- Fluid/Blood Leak32
- Break12
- Difficult to Flush11
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available31
- No Consequences Or Impact To Patient22
- Pain11
- Swelling/ Edema10
- Extravasation9
- Embolism/Embolus6
- Foreign Body In Patient6
Recent adverse event reports
The 25 most recent of 169 reports, 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 ↗InjuryDec 11, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I.ISP. IT WAS REPORTED THAT POST TO THE PROCEDURE THE MEDICATION LEAKED FROM THE CATHETER AND OBSERVED SWELLING UNDER THE PATIENT'S SKIN DURING HEPARIN LOCK PLACEMENT. CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Swelling/ Edema
MAUDE report 23775608 ↗InjuryDec 9, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP M.R.I. POST PROCEDURE WHILE DOING PORT REMOVAL AFTER CYCLE COMPLETED THAT TIME X-RAY WAS TAKEN, AND IT WAS FOUND THAT THE CATHETER WAS BROKEN AND WENT TO RA. BROKEN PART WAS REMOVED BY INTERVENTIONAL CARDIOLOGY IN OTHER HOSPITAL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23753230 ↗InjuryNov 3, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Material Integrity Problem; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Material Integrity Problem; Naturally Worn
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP M.R.I. POST THE PROCEDURE THE CATHETER WAS ALLEGEDLY DAMAGED. AND SUBCUTANEOUS LEAKAGE FROM THE CATHETER WAS CONFIRMED. ADDITIONALLY, THE PATIENT REPORTED PAIN DURING CATHETER INFUSE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 23448691 ↗InjuryOct 28, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY FOUND WITH A HOLE IN THE KIT AT THE 17 CM MARK. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED SUBCUTANEOUS LEAKAGE OF CHEMOTHERAPY DRUGS. NO SKIN NECROSIS OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Extravasation
MAUDE report 23400366 ↗MalfunctionOct 27, 2025Fracture; Material Separation; Obstruction of Flow; Fracture; Material Separation; Obstruction of Flow
IT WAS REPORTED THAT A CATHETER PLACED EARLIER WAS FOUND TO BE RUPTURED UPON REMOVAL. THE REMOVAL WAS PERFORMED ON (B)(6) 2018, DUE TO OBSTRUCTION, AND DURING THIS PROCESS, A CATHETER FRACTURE WAS CONFIRMED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389495 ↗MalfunctionOct 24, 2025Fracture; Fracture
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X-PORT ISP IMPLANTABLE PORT. IT WAS REPORTED THAT POST PROCEDURE, THE CATHETER ALLEGEDLY FOUND CRACKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376769 ↗MalfunctionOct 21, 2025Fracture; Fracture
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F. POST THE PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND TO BE CRACKED. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23345103 ↗MalfunctionOct 21, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING IMPLANTED PORT. DURING THE PROCEDURE, A CRACK WAS IDENTIFIED AT THE NECK CURVATURE OF THE GROSHONG CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23345064 ↗MalfunctionOct 7, 2025Reflux within Device; Reflux within Device
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING X-PORT ISP M.R.I. ON (B)(6) 2025, IT WAS REPORTED THAT THERE WAS A BACKFLOW ISSUE HAS BEEN IDENTIFIED WITH THE PORT WHERE THE CATHETER EXHIBITS BACKFLOW EVEN WITHOUT ANY ASPIRATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23230656 ↗InjuryOct 1, 2025Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. X-PORT ISP. POST THE PROCEDURE ON (B)(6) 2025, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY RUPTURED. THE MAIN BODY WAS REMOVED PERCUTANEOUSLY. IT WAS FURTHER REPORTED THAT THE RUPTURED CATHETER HAD MIGRATED INTO THE HEART AND WAS SUCCESSFULLY RETRIEVED USING A SNARE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23189582 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
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- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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