X-Port isp M.R.I. 0607555Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741026201), received between Apr 19, 2019 and Nov 4, 2025 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, 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 ↗
• 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 ↗
• MalfunctionSep 1, 2024Fracture; Difficult to Insert; Deformation Due to Compressive Stress; Fracture; Difficult to Insert; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PHYSICIAN ALLEGEDLY NOT ABLE TO INSERT THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH WAS ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115618 ↗
• InjuryMay 29, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE BROKEN CATHETER ALLEGEDLY MIGRATED TO SUPERIOR VENA CAVA. REPORTEDLY THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19413074 ↗
• MalfunctionFeb 13, 2024Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE PORT PLACEMENT PROCEDURE, THE ADAPTER THAT USES THE CONNECTION OF THE CATHETER TO THE PORT WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693666 ↗
• MalfunctionDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND BRUISING. THERE IS NO INFORMATION REGARDING THE MEDICAL INTERVENTION OR MEDICATION PRESCRIBED FOR THE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308652 ↗
• MalfunctionJul 6, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CONNECTOR WAS ALLEGEDLY BROKE WHILE INSERTION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265347 ↗
• MalfunctionJan 26, 2023Fracture; Material Separation; Material Integrity Problem; Fracture; Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PREPARATION OF A PORT PLACEMENT PROCEDURE, THE OUTLET FROM THE CHAMBER HAS BEEN FOUND DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245242 ↗
• MalfunctionJan 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY FOUND BROKEN AND DAMAGED WHILE GOING THROUGH CHEMOTHERAPY TREATMENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16172842 ↗
• MalfunctionAug 13, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY BROKEN FROM PORT JUNCTION UPON ATTACHING WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222487 ↗
• MalfunctionAug 8, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT PRIOR TO THE PORT PLACEMENT PROCEDURE, THE PORT STEM WAS ALLEGEDLY FRACTURED WHILE OPENING THE KIT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181830 ↗
• MalfunctionMar 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE PORT HUB ALLEGEDLY BROKE AT THE CONNECTOR POINT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13729242 ↗
• MalfunctionMay 6, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT PRIOR TO THE PORT PLACEMENT PROCEDURE, CONNECTER SITE OF PORT WAS ALLEGEDLY BROKEN WHILE CONNECTING CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782609 ↗
• MalfunctionJul 16, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0607555 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10283667 ↗