Smart Port CT CT66PTPDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H787CT66PTPD0), received between Jul 12, 2017 and Aug 23, 2022 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Material Puncture/Hole; Material Puncture/Hole

  AN END USER REPORTED AN ISSUE WITH A SMARTPORT CT PERIP. TITANIUM 6.6FR W/ POLY CATH. POST PROCEDURE, THE CATHETER DEVELOPED A HOLE. ULTIMATELY, THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278755 ↗
• DeathAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY HOSPITAL, "JULY 16TH OUTPATIENT PROCEDURE FOR A MEDIPORT PLACEMENT TO BE PERFORMED BY DR. (B)(6). THE PATIENT WAS DIAGNOSED WITH MULTIPLE MYELOMA. THE MEDIPORT WAS PLACED, NO DIFFICULTY WAS COMPLETED ON FIRST ATTEMPT. PROCEDURE WAS APPROX 30 MINUTES, PATIENT WAS AWAKENED WITH NO ISSUES AND TAKEN TO RECOVERY. THIS IS WHERE HE BECAME RESTLESS, UNRESPONSIVE AND PULSE LESS. CPR WAS STARTED AND AFTER MULTIPLE ATTEMPTS THE PATIENT DID NOT RESPOND AND EXPIRED AT 9:47. THE CORONER ARRIVED AND AN AUTOPSY WILL BE DONE". FOLLOW UP PHONE CALL WITH RISK MANAGER INDICATED THAT THE PATIENT DEATH WAS BELIEVED TO BE DUE TO THE "DISEASE PROCESS," NOT TO PORT (DEVICE) MALFUNCTION.

  Patient problems: Death

  MAUDE report 7806408 ↗
• InjuryFeb 26, 2018Fracture; Fracture

  AS REPORTED, PORT WHICH HAD BEEN IMPLANTED FOR APPROXIMATELY 4 YEARS WAS REMOVED ON (B)(6) 2018 DUE TO COMPLETION OF TREATMENT FOR CANCER. "UPON ATTEMPTED REMOVAL, THE PHYSICIAN WAS UNABLE TO REMOVE THE CATHETER AND NOTED SOME POTENTIAL DAMAGE AT THE SITE. PATIENT WAS REFERED TO INTERVENTIONAL RADIOLOGY. CATHETER WAS SUCCESSFULLY REMOVED, BUT THERE WAS SOME DAMAGE TO THE CATHETER NEAR WHERE IT PASSED UNDER THE SUBCLAVIAN VEIN." THE USED DEVICE WAS DISCARDED AT THE HOSPITAL. THE PATIENT CONDITION WAS LISTED AS "STABLE."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7295655 ↗
• MalfunctionFeb 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ANGIODYNAMICS' LEGAL DEPARTMENT RECEIVED NOTIFICATION FROM A PATIENT'S ATTORNEY THAT A SMART PORT HAD MALFUNCTIONED. THE UPN AND HOSPITAL NAME WERE PROVIDED, BUT NOT THE NATURE OF THE MALFUNCTION. A LETTER WITH POTENTIALLY MORE DETAILS IS EXPECTED.

  Patient problems: No Information

  MAUDE report 7272607 ↗
• MalfunctionJul 12, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON OCTOBER 05, 2016: THE PATIENT'S PORT WAS REMOVED FOR AN UNKNOWN ISSUE. UPON REMOVAL, IT WAS NOTED THE CATHETER HAD A TEAR IN IT APPROXIMATELY TWO INCHES FROM THE PORT. THE DEVICE WAS REPLACED WITH ANOTHER PORT. 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; No Known Impact Or Consequence To Patient

  MAUDE report 6705772 ↗