X-Port, ChronoFlex 0655870Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741026331), received between Jul 25, 2019 and Mar 18, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Fluid/Blood Leak; Fracture; Material Puncture/Hole; Suction Problem; Difficult to Advance; Fluid/Blood Leak; Fracture; Material Puncture/Hole; Suction Problem; Difficult to Advance

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE; THE CATHETER ALLEGEDLY HAD FRACTURED, AND THE PATIENT HAD ALSO ALLEGEDLY DEVELOPED WITH INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21628764 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Defective Component; Obstruction of Flow; Fluid/Blood Leak; Defective Component; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, LEAK WAS IDENTIFIED IN HUBBER NEEDLE TUBING AND THE BRANCH OFF THE LEUR LOCK SITE. IT WAS FURTHER REPORTED THAT PORT WAS ALLEGEDLY CLOTTED. ADDITIONALLY, THE NEEDLE WAS ALLEGEDLY TOO SHORT AND BECAUSE OF THIS LEAKAGE OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429541 ↗
• MalfunctionMar 21, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT ONE MONTH AND EIGHT DAYS POST PORT PLACEMENT, A HOLE WAS ALLEGEDLY FOUND IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE DRUG HAD ALSO FLOWED INTO THE TISSUE. IT WAS ALSO REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN. HOWEVER, THERE IS NO INFORMATION PROVIDED REGARDING ADDITIONAL MEDICAL INTERVENTION NOR MEDICATION PRESCRIBED TO TREAT THE PAIN. REPORTEDLY THE PORT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580454 ↗
• MalfunctionMar 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT ONE MONTH AND EIGHT DAYS POST PORT PLACEMENT, THE TEAR ALLEGEDLY OCCURRED AT ABOUT 50 CM AND WAS IDENTIFIED UNDER FLUOROSCOPY USING A CONTRAST AGENT. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED ARM PAIN AND WARM AT FIRST DUE TO TEAR. REPORTEDLY, THE PORT SYSTEM WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485832 ↗
• MalfunctionOct 26, 2020Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE MODEL 0655870 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED GUIDEWIRE MISSING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10738073 ↗
• InjuryJul 25, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT IN A CUBITAL VEIN, A THROMBUS WAS ALLEGEDLY FORMED IN THE CATHETER IN THE SUBCLAVIAN VEIN, IDENTIFIED VIA MRI. IT WAS FURTHER REPORTED THAT UPON FLUOROSCOPY, A HOLE IN THE CATHETER APPROXIMATELY 5 TO 10 CM ABOVE THE PORT CHAMBER WAS ALLEGEDLY IDENTIFIED. REPORTEDLY, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS PLACED IN THE OTHER ARM. THE PATIENT WAS REPORTED STABLE POST REMOVAL AND REPLACEMENT PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 8828513 ↗