BardPort M.R.I. 0602690Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741025686), received between Oct 17, 2019 and Aug 3, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Difficult to Remove; Failure to Advance

  On (b)(6)2026, a patient underwent a port placement procedure using an M.R.I. Port. During the procedure, a defect was identified in the needle, preventing it from moving in either direction. The needle could neither advance nor retract. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112403 ↗
• MalfunctionNov 11, 2025Device Markings/Labelling Problem; Component Missing; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT BARD PORT DRESSINGS ASSOCIATED WITH THE M.R.I. PORT ARE BEING RECEIVED WITHOUT THE IDENTIFICATION LABEL. IN THE PROVIDED EXAMPLE (CIRCLED IN RED), THE LABEL IS MISSING FROM THE PACKAGING, WHICH MAY LEAD TO TRACEABILITY AND USAGE CONCERNS IN CLINICAL SETTINGS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520819 ↗
• MalfunctionNov 11, 2025Device Markings/Labelling Problem; Component Missing; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT BARD PORT DRESSINGS ASSOCIATED WITH THE M.R.I. PORT ARE BEING RECEIVED WITHOUT THE IDENTIFICATION LABEL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520817 ↗
• MalfunctionAug 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON 25-JULY-2025, PRIOR TO A PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT A BOX LABELED WITH SKU 0602690 ACTUALLY CONTAINED 05 UNITS OF SKU 0604580. IT WAS FURTHER REPORTED THAT ALL PRODUCTS IN THIS BOX WERE LABELED WITH THE CODE 0602690. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870836 ↗
• MalfunctionAug 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, PRIOR TO A PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT A BOX LABELED WITH SKU 0602690 ACTUALLY CONTAINED 05 UNITS OF SKU 0604580. IT WAS FURTHER REPORTED THAT ALL PRODUCTS IN THIS BOX WERE LABELED WITH THE CODE 0602690. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870825 ↗
• MalfunctionAug 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON 25-JULY-2025, PRIOR TO A PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT A BOX LABELED WITH SKU 0602690 ACTUALLY CONTAINED 05 UNITS OF SKU 0604580. IT WAS FURTHER REPORTED THAT ALL PRODUCTS IN THIS BOX WERE LABELED WITH THE CODE 0602690. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870816 ↗
• MalfunctionAug 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, PRIOR TO A PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT A BOX LABELED WITH SKU 0602690 ACTUALLY CONTAINED (B)(4) UNITS OF SKU 0604580. IT WAS FURTHER REPORTED THAT ALL PRODUCTS IN THIS BOX WERE LABELED WITH THE CODE 0602690. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870813 ↗
• MalfunctionAug 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, PRIOR TO A PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT A BOX LABELED WITH SKU 0602690 ACTUALLY CONTAINED 05 UNITS OF SKU 0604580. IT WAS FURTHER REPORTED THAT ALL PRODUCTS IN THIS BOX WERE LABELED WITH THE CODE 0602690. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870812 ↗
• InjuryNov 29, 2024Fracture; Device Tipped Over; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Device Tipped Over; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT ALLEGEDLY HAD CATHETER FRACTURE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED WITH AN INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Purulent Discharge; Sepsis; Unspecified Infection; Wound Dehiscence

  MAUDE report 20810707 ↗
• InjuryNov 30, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT ONE YEAR, EIGHT MONTHS AND FOURTEEN DAYS POST A PORT PLACEMENT, THE PERIPHERAL ARTERIAL CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE DISTAL END WAS MIGRATED INTO THE LUNG THROUGH THE HEART. REPORTEDLY, THE PERIPHERAL ARTERIAL CATHETER CASING WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 18236120 ↗
• MalfunctionSep 5, 2023Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, WHEN OPENING THE PRODUCT BOX, THE CATHETER WAS ALLEGEDLY FOUND TO BE DISASSEMBLED. IT WAS FURTHER REPORTED THAT THE CATHETER SIZE DESCRIBED IN THE PRODUCT BOX WAS ALLEGEDLY DIFFERENT THAN THE CATHETER PRESENT INSIDE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681643 ↗
• MalfunctionOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602690, IMPLANTABLE PORT, ALLEGEDLY EXPERIENCED A SEPTUM DISLODGEMENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205776 ↗