BardPort 0603006Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741025792), received between May 10, 2019 and Mar 18, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• MalfunctionMar 18, 2026Difficult to Flush

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE PERITONEAL PORT. DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE COULD NOT BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629360 ↗
• InjuryMay 8, 2022Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND FOUR MONTHS POST PORT IMPLANT PROCEDURE, THE TIP OF THE CATHETER WAS ALLEGEDLY MIGRATED INTO THE SIGMOID COLON. IT WAS FURTHER REPORTED THAT THE SURGERY WAS PERFORMED DUE TO CATHETER MIGRATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14332450 ↗
• MalfunctionFeb 16, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE CATH-LOCK OVER SLEEVE ALLEGEDLY DISCONNECTED. IT WAS FURTHER REPORTED THAT INTRAPERITONEAL ADMINISTRATION HAD BEEN COMPLETED WHEN THE CATH-LOCK OVER SLEEVE WAS FOUND TO HAVE DISCONNECTED. REPORTEDLY, DUE TO THE SHIFT TO PALLIATIVE MEDICINE, THE PORT SYSTEM AND THE CATH-LOCK OVER SLEEVE WERE NOT REMOVED. THE DEVICE REMAINED IN THE PATIENT AND SHIFTED TO PALLIATIVE CARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540111 ↗
• MalfunctionJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT CATH-LOCK OVER SLEEVE OF A MODEL 0603006 IMPLANTABLE PORT ALLEGEDLY DISCONNECTED . THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED TO BE A 37-YEAR-OLD FEMALE, WEIGHT WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822138 ↗
• MalfunctionJul 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT PART OF A MODEL 0603006 PORT & CATHETER WAS ALLEGEDLY NOT REMOVED BY PHYSICIAN. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED AN ALLERGIC REACTION TO THE CATHETER. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800099 ↗
• InjuryMay 10, 2019Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT PLACEMENT ON THE LEFT SIDE DISTAL TO THE SEVENTH RIB, A PORTION OF THE PORT WAS ALLEGEDLY REMOVED. IT WAS FURTHER REPORTED THAT APPROXIMATELY TEN YEARS POST PORT REMOVAL, THE PATIENT ALLEGED A SMALL PAINFUL FLUID-FILLED AREA NEAR THE SITE OF THE PERITONEAL PORT. FURTHER, A CT SCAN ALLEGEDLY IDENTIFIED A 7-8MM DENSE MAN MADE FOREIGN OBJECT, POSSIBLY THE COLLAR THAT CONNECTED THE PORT TO THE CATHETER, UNDERNEATH THE SKIN OF THE SAME LOCATION. REPORTEDLY, A NEW PORT WILL BE PLACED AT WHICH TIME THE FOREIGN OBJECT WILL BE REMOVED. THE PATIENT WAS REPORTEDLY STABLE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 8600938 ↗