Smart Port CT CT66PTPD-VIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787CT66PTPDVI1), received between Apr 12, 2017 and May 22, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Aspiration Issue” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2019Difficult to Flush; Infusion or Flow Problem; Difficult to Flush; Infusion or Flow Problem

  ANGIODYNAMICS NOTIFIED VIA USER MEDWATCH # (B)(4) OF A SMART PORT WHICH WAS REMOVED/EXPLANTED DUE TO THE USER'S INABILITY TO FLUSH AND DRAW BLOOD FROM THE DEVICE. ANOTHER PORT WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631247 ↗
• InjuryJul 12, 2017Crack; Fracture; Leak/Splash; Crack; Fracture; Leak/Splash

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: SMART PORT MINI NEEDED TO BE REMOVED DUE TO FRACTURED CATHETER. CATHETER WAS PLACED IJ (INTERNAL JUGULAR VEIN), NOT SUBCLAVIAN. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6706006 ↗
• MalfunctionApr 12, 2017Aspiration Issue; Aspiration Issue

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: PORT HAD STOPPED WORKING (UNABLE TO ASPIRATE), AND WAS BROUGHT INTO THE IR LAB FOR ANALYSIS. FLUORO. IMAGES SHOWED AN AREA MID-CATHETER WHERE IT APPEARED THAT THE CATHETER WAS BEING COMPRESSED BY SOME SORT OF MATERIAL BUILD-UP ON THE EXTERIOR OF THE CATHETER. A DYE TEST WAS PERFORMED AND THE CATHETER SHOWED NO LEAKAGE. THE PORT WAS REMOVED AND UPON REMOVAL, IT WAS OBSERVED THAT THE EXTERNAL SURFACE OF THE CATHETER WAS COATED WITH SOME SORT OF "GRITTY" PRECIPITATE. IT WAS ALSO OBSERVED THAT THE CATHETER HAD A NOTICEABLE SPLIT IN THE CATHETER WHERE THE OBSERVED COMPRESSION WOULD'VE BEEN. DR. RIVARD WAS NOT CONVINCED THAT THE SPLIT WAS THERE PRIOR TO REMOVAL SINCE THE DYE TEST SHOWED NO LEAKAGE. HE FELT THAT IT MAY HAVE SPLIT UPON REMOVAL. DR. RIVARD HAS ALSO OBSERVED THIS PHENOMENA ("GRITTY" DEPOSITS ON CATHETER SHEATH.) IN THE PAST WITH ACUTE LEUKEMIA PATIENTS. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 6486944 ↗