BardPort 0604970Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741025884), received between Sep 14, 2018 and Mar 30, 2026 — classified as 1 death, 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• DeathMar 30, 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 24726864 ↗
• MalfunctionAug 12, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781525 ↗
• InjuryJun 20, 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, THE PATIENT DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22296953 ↗
• MalfunctionApr 28, 2025Fracture; Fracture

  ON (B)(6) 2003, PATIENT UNDERWENT BARD SLIMPORT DUAL-LUMEN ROSENBLATT IMPLANTABLE PORT PLACEMENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION. ABOUT SOMETIMES POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY HAD FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916480 ↗
• InjuryFeb 11, 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 A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21353796 ↗
• MalfunctionFeb 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PREPARATION OF PORT PLACEMENT PROCEDURE, THE TIP WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341800 ↗
• MalfunctionFeb 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PREPARATION OF PORT PLACEMENT PROCEDURE, THE TIP WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341625 ↗
• MalfunctionJan 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY LEAKED WHILE FLUSHING. IT WAS FURTHER REPORTED THAT 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 16245180 ↗
• MalfunctionApr 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE TIP OF THE DILATOR WAS ALLEGEDLY NOTED TO BE SPLIT/FRAYED UPON OPENING THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14081967 ↗
• MalfunctionOct 27, 2021Difficult to Flush; Difficult to Flush

  IT WAS FURTHER REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY UNABLE TO BE FLUSHED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704636 ↗
• MalfunctionMar 8, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE COULDN'T ATTACH THE CATHETER TO THE CHAMBER HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441255 ↗
• MalfunctionFeb 25, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOME TIME POST PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD DROPLETS WHEN CONNECTED TO THE DUAL PORT HUB. IT WAS FURTHER REPORTED THAT ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377003 ↗
• MalfunctionOct 17, 2019Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0604970. IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A FRACTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205802 ↗
• MalfunctionOct 17, 2019Crack; Crack

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0604970 PORT AND CATHETER ALLEGEDLY EXPERIENCED A CRACK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) OLD AND WEIGHS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205798 ↗
• MalfunctionSep 14, 2018Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PATIENT¿S DUAL PORT WOULD NOT ASPIRATE OR INFUSE. DURING THE PATIENT¿S CHEMOTHERAPY TREATMENT ONLY ONE PORT WORKED AND HE HAD TO HAVE AN IV PLACED FOR FLUIDS. APPROXIMATELY ONE WEEK AGO BOTH PORTS STOPPED WORKING AND THE PATIENT HAD TO HAVE CHEMOTHERAPY THROUGH HIS IV. THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7879531 ↗