BardPort M.R.I., ChronoFlex 0605640Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00801741025990), received between Apr 26, 2018 and Aug 5, 2026 — classified as 10 injuries, 37 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Fracture; Material Separation; Migration

  In 2023, a patient underwent a port placement procedure using an M.R.I. Ultra Slim Port. Post the procedure on (b)(6) 2026, it was reported that the catheter had fractured at the catheter-to-port connection site. It was further reported that a catheter fragment had migrated toward the heart. The device was subsequently removed. The patient's current condition is reported as stable.

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

  MAUDE report 50137688 ↗
• MalfunctionNov 18, 2025Degraded; Entrapment of Device; Fracture; Difficult to Remove; Material Too Rigid or Stiff; Material Separation; Deformation Due to Compressive Stress; Material Deformation; Naturally Worn; Degraded; Entrapment of Device; Fracture; Difficult to Remove; Material Too Rigid or Stiff; Material Separation; Deformation Due to Compressive Stress; Material Deformation; Naturally Worn

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. ULTRA SLIMPORT ON SIX MONTHS AGO. ON (B)(6) 2025, POST THE PROCEDURE WHILE REMOVAL OF THE PORT FROM PATIENTS' BODY, THE CATHETER TENDS TO STICK TO THE VEIN WALL AND GETS STUCK. THIS CAUSES ISSUES FOR THE SURGEON TO REMOVE THE OLD PORT. THEY ALSO OBSERVED THE CATHETER MATERIAL SEEMED HARDER AND STIFFER THAN A NEW PORT CATHETER SUSPECTING CHANGE IN MATERIAL OVER TIME. NEED TO ACCESS THE FEMORAL SITE TO ACCESS THAT PART OF THE VEIN AND SLOWLY REMOVE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579520 ↗
• InjurySep 10, 2025Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A M.R.I. ULTRA SLIMPORT PLACEMENT PROCEDURE, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT AIR WAS ENTERING THROUGH THE PINK NEEDLE. ADDITIONALLY, IT WAS REPORTED THAT EMBOLISM WAS OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 23013012 ↗
• MalfunctionJul 24, 2025Separation Failure; Separation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A MR CHRONO PORT PLACEMENT PROCEDURE USING THE MRI ULTRA SLIMPORT IMPLANTABLE PORT. DURING THE PROCEDURE THE SHEATH ALLEGEDLY COULD NOT BE PEELED OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584755 ↗
• InjuryJun 4, 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 UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22138826 ↗
• MalfunctionFeb 3, 2025Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT THREE YEARS AND TWO DAYS POST A PORT PLACEMENT, THE BLOOD WAS ALLEGEDLY NOT ABLE TO BE DRAWN OR TRANSFUSED. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300492 ↗
• InjuryJan 17, 2025Difficult to Insert; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Insert; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY FOUND TO BE STUCK IN THE INTRODUCER NEEDLE UNDER X-RAY IMAGING. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE NEEDLE. FURTHERMORE, THE PATIENT'S SUBCLAVIAN VEIN WAS ALLEGEDLY TORN DUE TO THIS. MOREOVER, THE PATIENT HAD ALLEGEDLY BECAME TACHYCARDIC WHICH WAS MANAGED BY ANESTHESIA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Tachycardia; Vascular Dissection

  MAUDE report 21178947 ↗
• InjuryAug 21, 2024Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Migration; Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY FIVE YEARS POST A PORT PLACEMENT IN THE FOREARM, THE PORT WAS ALLEGEDLY NOT USED FOR FOUR YEARS. IT WAS FURTHER REPORTED THAT WHEN TRIED TO REMOVE IT, IT PULLED OUT ABOUT TEN CENTIMETER FROM THE PORT AND ALLEGEDLY COULD NOT REMOVE THE CATHETER AFTER THAT. ADDITIONALLY, FLUOROSCOPIC CONFIRMATION SHOWED THAT THE CATHETER WAS FRACTURED IN THE MIDDLE OF THE ARM AND REMAINED IN THE BLOOD VESSEL. REPORTEDLY, THE VESSEL WAS LIGATED WITH A CUT DOWN LIGATURE AND RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20020372 ↗
• MalfunctionMar 22, 2024Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY DIFFICULT TO FLUSH. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD NO BLOOD RETURN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957294 ↗
• MalfunctionMar 13, 2024Fracture; Suction Problem; Fracture; Suction Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE BLOOD ALLEGEDLY FAILED TO BACKFLOW WHEN THE SYRINGE WAS CONNECTED TO THE NEEDLE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892669 ↗
• InjuryDec 30, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE DEVICE ALLEGEDLY HAD A SUBCUTANEOUS LEAKAGE. REPORTEDLY, THE PORT SYSTEM WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422811 ↗
• MalfunctionOct 25, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE HUB OF THE PUNCTURE NEEDLE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18001848 ↗
• MalfunctionMar 2, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT FOUR MONTHS AND TWENTY-SIX DAYS POST PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND DETACHED FROM PORT BODY. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465742 ↗
• MalfunctionJan 25, 2023Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE DEVICE WAS ALLEGEDLY UNABLE TO BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238625 ↗
• InjuryJan 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY FIVE YEARS POST PORT PLACEMENT ON THE UPPER ARM, THE PORT ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PORT SYSTEM WAS REMOVED AND REPLACED WITH ANOTHER NEW PORT SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16167445 ↗
• MalfunctionOct 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, A CRACK ALLEGEDLY FORMED ON THE HUB OF THE INTRODUCER NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691019 ↗
• MalfunctionOct 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, A CRACK ALLEGEDLY FORMED ON THE HUB OF THE INTRODUCER NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690429 ↗
• MalfunctionMay 5, 2022Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT IMMEDIATELY POST PORT PLACEMENT PROCEDURE, THE PORT SYSTEM COULD NOT BE INFUSED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285177 ↗
• MalfunctionFeb 1, 2022Difficult to Remove; Stretched; Material Protrusion/Extrusion; Difficult to Remove; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY FIVE YEARS POST PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND TO BE BULGING NEAR THE DISTAL END. IT WAS FURTHER REPORTED THAT THE CATHETER PORT ALLEGEDLY HAD DIFFICULTY ON REMOVING AND ADHERED TO THE TISSUES. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 13411091 ↗
• MalfunctionAug 17, 2021Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND ON THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329663 ↗
• MalfunctionAug 4, 2021Fracture; Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY STUCK IN THE INTRODUCER NEEDLE AND COULD NOT BE REMOVED FROM THE INTRODUCER NEEDLE. THE GUIDEWIRE AND THE INTRODUCER NEEDLE WERE REMOVED TOGETHER AND DAMAGE WAS FOUND ON THE REMOVED GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272800 ↗
• MalfunctionJun 4, 2021Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, WHEN THE INTRODUCTION NEEDLE WAS ATTEMPTED TO BE ASPIRATED, AIR WAS ALLEGEDLY ASPIRATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937031 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT ON RIGHT SIDE UPPER CHEST , THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND PRESSURE DURING FLUSHING . THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11806124 ↗
• MalfunctionMar 16, 2021Fracture; Stretched; Fracture; Stretched

  IT WAS REPORTED THAT DURING PORT DEVICE IMPLANT PROCEDURE, THE GUIDEWIRE WAS EXTENDED UPON WITHDRAWAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494539 ↗
• MalfunctionFeb 12, 2021Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT, THE DEVICE ALLEGEDLY SEEMED TO BE DIRTY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320510 ↗