X-Port M.R.I., ChronoFlex 0607530Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741026171), received between Jan 12, 2017 and Sep 4, 2026 — classified as 2 deaths, 9 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Component Missing; Device Markings/Labelling Problem; Missing Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50608087 ↗
• MalfunctionSep 4, 2026Component Missing; Device Markings/Labelling Problem; Missing Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50608084 ↗
• MalfunctionMar 26, 2026Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697121 ↗
• InjuryAug 4, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22697957 ↗
• InjuryJun 16, 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 POST A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22209238 ↗
• InjuryMay 8, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  ON (B)(6) 2023, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE, USING X-PORT ISP IMPLANTABLE PORT, FOR AN UNKNOWN MEDICAL CONDITION. ONE YEAR, TEN MONTHS AND SIXTEEN DAYS POST PORT PLACEMENT, ON (B)(6) 2025, WHILE UNDERGOING AN INFUSION, IT WAS REPORTED THAT THE CHAMBER WAS ALLEGEDLY LEAKING. X-RAY CARRIED OUT AND REVEALED NO VISUALIZATION OF THE CHAMBER IN THE SUBCLAVIAN, VISUALIZATION OF THE CATHETER ALONE WAS OBSERVED. THERE WERE VISIBLE SIGNS OF DIFFUSION: REDNESS, OEDEMA, ALONG WITH EXTRAVASATION. THE PORT WAS IMMEDIATELY AND REPLACED WITH ANOTHER PAC IN THE LEFT INTERNAL JUGULAR VEIN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 21984533 ↗
• MalfunctionDec 13, 2024Defective Component; Component Misassembled; Defective Component; Component Misassembled

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER LOCK WAS ALLEGEDLY ATTACHED IN REVERSE. IT WAS FURTHER REPORTED THAT THE REVERSE ATTACHMENT WAS NOTICED DURING THE CONNECTION PROCESS AND REATTACHED IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921734 ↗
• InjuryOct 1, 2024Fluid/Blood Leak; Fracture; Material Separation; Migration; Fluid/Blood Leak; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340984 ↗
• InjurySep 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 20275021 ↗
• MalfunctionSep 2, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY HAD A BROWN FOREIGN OBJECT FOUND ATTACHED TO THE PRODUCT SEAL INSIDE THE INDIVIDUAL PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118380 ↗
• MalfunctionJan 18, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A DEFECT IN THE SHAPE OF THE SUTURE HOLE SILICONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532526 ↗
• InjuryOct 27, 2023Fluid/Blood Leak; Fracture; Material Opacification; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Material Opacification; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED SWELLING OF THE NECK WITH CERVICAL EDEMA OF THE PORT LODGE. IT WAS FURTHER REPORTED THAT THE HEALTHCARE PERSONNEL IMMEDIATELY CEASED THE INFUSION OF THE CHEMOTHERAPY TO PREVENT HARM TO THE PATIENT AND A FIVE-MILLILITER OF THE BLOOD WAS ASPIRATED TO REMOVE AS MUCH OF THE INFUSED FLUID. IT WAS ALSO REPORTED THAT THE CATHETER WAS ALLEGEDLY OPACIFIED AND RUPTURED, AND CONFIRMED A LEAK ON THE CHAMBER PATH WITH EXTRAVASATION OF CAELYX-TYPE CHEMOTHERAPY ON THE CATHETER. FURTHERMORE, SWELLING AND EXTRAVASATION WAS CAUSED DUE TO PERFORATION OF THE CENTRAL PATHWAY. REPORTEDLY, ICE PACK WAS APPLIED TO REDUCE THE PRODUCT DIFFUSION AND TOPICAL CORTICOSTEROID WAS APPLIED TO TREAT SWELLING AND EXTRAVASATION. THE PORT WAS REMOVED WITH VISUALIZATION OF THE BREACH IN THE CATHETER. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 18019753 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Fracture; Material Opacification; Fluid/Blood Leak; Fracture; Material Opacification

  IT WAS REPORTED THAT TEN MONTHS AND SEVENTEEN DAYS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY HAD OPACIFICATION. IT WAS ALSO FURTHER REPORTED THAT THE CATHETER ALLEGEDLY FRACTURED. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236284 ↗
• MalfunctionAug 5, 2022Material Discolored; Fracture; Dent in Material; Material Discolored; Fracture; Dent in Material

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173468 ↗
• MalfunctionApr 1, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT APPROXIMATELY EIGHT YEARS AND TEN MONTHS POST PORT IMPLANT IN THE LEFT SUBCLAVIAN VEIN AND UPON REMOVAL, A TWO CENTIMETER LONG DEVICE FRAGMENT WAS RETAINED WITHIN THE WALL OF THE LEFT SUBCLAVIAN VEIN. THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975299 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE TUBING STEM OF THE IMPLANTABLE CHAMBER WAS ALLEGEDLY DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806269 ↗
• MalfunctionMay 5, 2021Fracture; Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Device-Device Incompatibility; Fracture; Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE NEEDLE ALLEGEDLY HAD DIFFICULTY TO REMOVE AND IT HOOKED WITH GUIDEWIRE. IT WAS FURTHER REPORTED THAT PHYSICIAN HAD TO FORCE TO WITHDRAW THE NEEDLE, THE GUIDEWIRE BECAME FRAYED. REPORTEDLY PHYSICIAN SUSPECTED THAT FRAGMENT REMAINED IN THE VESSEL BUT NOTHING WAS OBSERVED ON FLUORESCENCE CONTROL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778026 ↗
• InjuryMar 15, 2021Difficult to Insert; Deformation Due to Compressive Stress; Material Twisted/Bent; Difficult to Insert; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DILATOR WAS ALLEGEDLY DIFFICULT TO INSERT, TWISTED INTO THE PATIENT AND KINK WAS NOTED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN, TRAUMATIZED AND THERE WAS A RISK OF BLEEDING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11483336 ↗
• MalfunctionDec 21, 2020Suction Problem; Failure to Infuse; Suction Problem; Failure to Infuse

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST PORT PLACEMENT, THE DEVICE ALLEGEDLY FAILED TO INFUSE AND FAILED TO ASPIRATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11044865 ↗
• MalfunctionNov 10, 2020Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST PLACEMENT, THE DEVICE ALLEGEDLY UNABLE TO INFUSE AND THE CATHETER WAS ALLEGEDLY FOUND OCCLUDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10814695 ↗
• MalfunctionOct 28, 2020Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT THE PORT SYSTEM WAS ALLEGEDLY FAILED TO INFUSE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10747333 ↗
• DeathJul 14, 2020Entrapment of Device; Fracture; Stretched; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Fracture; Stretched; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT THROUGH RIGHT CEPHALIC, THE METALLIC GUIDE STRETCHED ALLEGEDLY IN THE PINK PUNCTURE NEEDLE WITH AN IMPOSSIBLE MOBILIZATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT WAS EXPIRED.

  Patient problems: Death

  MAUDE report 10269152 ↗
• MalfunctionOct 18, 2019Defective Component; Tear, Rip or Hole in Device Packaging; Defective Component; Tear, Rip or Hole in Device Packaging

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0607530 IMPLANTED PORT ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT AND COMPONENT CAUGHT IN SEAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVED A PATIENT WITH PATIENT STATUS UNKNOWN. THE PATIENT AGE, GENDER, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9209390 ↗
• MalfunctionOct 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0607530 PORT AND CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209193 ↗
• MalfunctionJul 16, 2019Fracture; Defective Component; Fracture; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0607530. PORT CATHETER ALLEGEDLY FRACTURE, AND DEFECTIVE COMPONENTS. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796451 ↗