BardPort, ChronoFlex 0605510Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741025969), received between Apr 19, 2019 and Mar 26, 2026 — classified as 1 death, 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24695679 ↗
• MalfunctionAug 28, 2025Disconnection; Disconnection

  ON (B)(6) 2012, THE DEVICE WAS IMPLANTED. IT WAS REPORTED THAT POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY FOUND DISCONNECTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910564 ↗
• MalfunctionJul 23, 2025Peeled/Delaminated; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Peeled/Delaminated; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING CHRONO TITANIUM PORT. DURING PREPARATION OF THE PROCEDURE IT WAS NOTED THAT, THE PACKAGING WAS STUCK TO THE INNER PACKAGING, WHICH CAUSED THE DEVICE TO LOSE ITS STERILITY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574214 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; 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 22326603 ↗
• InjuryNov 12, 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 WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20663149 ↗
• MalfunctionMar 31, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A LEAKAGE WHEN CONNECTED THE SYRINGE TO THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13963073 ↗
• InjurySep 3, 2021Fluid/Blood Leak; Fracture; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST PORT PLACEMENT PROCEDURE, A PERFORATION WAS ALLEGEDLY NOTED IN SUPRACLAVICULAR RIGHT UPSTREAM OF THE PORTION AND EDEMA ABOVE THE RIGHT CLAVIAN. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Extravasation; Perforation of Vessels; Swelling/ Edema

  MAUDE report 12419324 ↗
• MalfunctionMay 18, 2021Fracture; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Stretched; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE GUIDE WAS ALLEGEDLY GOT STUCK IN THE NEEDLE PUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841757 ↗
• InjuryMar 31, 2021Material Discolored; Fluid/Blood Leak; Fracture; Material Discolored; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT ALLEGEDLY HAD PAIN AND SWELLING UPSTREAM. IT WAS FURTHER REPORTED THAT THE SALINE SOLUTION LEAKED AND TUBING LEVEL ALLEGEDLY CRACKED. REPORTEDLY, THE DEVICE WAS REMOVED. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 11594383 ↗
• MalfunctionMar 31, 2021Component Missing; No Apparent Adverse Event; Missing Information; Component Missing; No Apparent Adverse Event; Missing Information

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE PRESSURE INDICATION WAS ALLEGEDLY MISSING ON THE PATIENT CARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593780 ↗
• MalfunctionJul 24, 2019Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0605510CE PORT & CATHETER ALLEGEDLY EXPERIENCED AN INCOMPATIBLE COMPONENT AND MATERIAL FRAYED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822592 ↗
• MalfunctionApr 19, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES TWO (2) MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0605510 IMPLANTABLE PORT EXPERIENCED A DEFECTIVE COMPONENT. THESE EVENTS WERE REPORTED FROM VARIOUS SOURCES. BOTH EVENTS INVOLVED PATIENTS WITH NO REPORTED INJURY. THE PATIENTS¿ AGE, WEIGHT, AND SEX WERE NOT PROVIDED FOR EITHER OF THE TWO (2) EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532859 ↗
• MalfunctionApr 19, 2019Failure to Infuse; Failure to Infuse

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0605510 IMPLANTABLE PORT EXPERIENCED A FAILURE TO INFUSE. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT'S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532760 ↗