Smart Port CT CT66LTPD-VIRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI H787CT66LTPDVI1), received between Aug 10, 2020 and Jan 14, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5546142. THE DEVICE WAS IMPLANTED BY (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21151830 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN EVENT THAT OCCURRED WITH A PATIENT THAT HAD A PREVIOUSLY REMOVED PORT FROM A TANDEM CT LOWPROFILE WITH VALVED INTRODUCER SMARTPORT KIT. ON (B)(6) 2023, A PATIENT UNDERWENT BILATERAL MASTECTOMY AND LEFT MEDIPORT REMOVAL. PATIENT NO LONGER REQUIRED THE PORT BECAUSE CHEMOTHERAPY WAS COMPLETED. ON (B)(6) 2023, THE PATIENT RETURNED TO THE OR FOR RE-EXCISION OF RIGHT BREAST. AN INTRA-OPERATIVE X-RAY WAS DONE. X-RAY SHOWED MEDIPORT METALLIC CUFF RETAINED FROM PREVIOUS SURGERY. PATIENT AND FAMILY MEMBER WERE NOTIFIED, CONSENT WAS OBTAINED, AND RETAINED MEDI-PORT PIECE WAS REMOVED. PATIENT AND SURGEON CONFIRMED THAT RETAINED PIECE COULD BE PALPATED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645609 ↗
• MalfunctionJan 31, 2023Inability to Irrigate; Failure to Infuse; Inability to Irrigate; Failure to Infuse

  A CLINICAL SPECIALIST REPORTED A PATIENT EXPERIENCED WITH A SMARTPORT FROM A TANDEM CT LOWPROFILE WITH VALVED INTRODUCER SMARTPORT KIT. THE CS RECEIVED A CALL FROM THE PATIENT, AND THEN THE PATIENT PROVIDED AN EMAIL WITH THE FOLLOWING INFORMATION: THE PHYSICIAN WHO ORDERED THE PORT WAS DR. (B)(6). THE PHYSICIAN WHO PLACED THE PORT ON (B)(6) 2022 WAS DR. (B)(6) WITH THEIR RESIDENT PHYSICIAN (B)(6). BETWEEN 09/02 AND 12/17, SHE HAD 4 EMERGENCY ROOM VISITS DUE TO ISSUES WITH THE PORT NOT FLUSHING, ACCESS, AND RESISTANCE. IT'S OVERWHELMINGLY FRUSTRATING HAVING TO MISS WORK PLUS SCHOOL TO GO TO THE EMERGENCY ROOM TO GET THE PORT FLUSH PLUS HAVING TO SIT THERE 18 PLUS HOURS ONLY TO BE TOLD BY THE EMERGENCY ROOM THEY CANNOT DO ANYTHING. THEN MISS A DAY OF WORK TO GET A PROCEDURE DONE TO GET THE PORT CHECKED OUT, NOT ONCE TO HAVE IT PLACED ((B)(6) 2022), NOT TWICE TO HAVE IT EVALUATED IN IR ((B)(6) 2022), BUT NOW THREE TIMES TO HAVE IT REPLACED ON (B)(6) 2023. ON (B)(6) 2022 - PHYSICIAN (B)(6) ORDERED AN IR CVAD RESERVOIR REPAIR / PORT EVALUATION DUE TO THE EMERGENCY ROOM BEING UNABLE TO FLUSH THE PORT ON (B)(6). EMERGENCY ROOM HAD TRIED VARIOUS TIMES TO ACCESS AND FLUSH PORT WITH NOTHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273427 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT POST PROCEDURE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION OR PATIENT COMPLICATION DURING THE PORT PLACEMENT PROCEDURE OR DURING USE OF THE PORT. A PATIENT EXPERIENCED AN ISSUE WHEN USING A CT LOW PROFILE WITH VALVED INTRODUCER SMART PORT. THE PATIENT HAD BEEN DIAGNOSED WITH LEFT BREAST INVASIVE DUCTAL CARCINOMA WITH AXILLARY LYMPH NODE INVOLVEMENT, THEREFORE, A SMART PORT VORTEX SAFE SHEATH ULTRA LITE PORT WAS IMPLANTED (RIGHT INTERNAL JUGULAR) ON (B)(6) 2022 AT (B)(6)HOSPITAL. THE PORT NEVER FELT RIGHT TO THE PATIENT. ON (B)(6) 2022, THE PATIENT RECEIVED CHEMOTHERAPY AND IMMUNOTHERAPY (PTCH ) AT A CHEMO INFUSION CENTER. THE PORT CONNECTOR WAS ACCESSED ONCE FOR A BLOOD DRAW AND ONCE TO ADMINISTER CHEMO. IT WAS CLEANED WITH ALCOHOL BEFORE USE BOTH TIMES. ON (B)(6) 2022, PATIENT DEVELOPED LOW GRADE FEVER (100.4). THE PATIENT CALLED THE ON CALL PHYSICIAN WHO INFORMED THE PATIENT TO TAKE TYLENOL AND CALL BACK IF TEMPERATURE GETS WORSE. OVER THE NEXT COUPLE OF DAYS ((B)(6) 2022 THROUGH (B)(6) 2022), THE PATIENT BECAME PROGRESSIVELY DELIRIOUS/CONFUSED. ON (B)(6) 2022 THE PATIENT WAS TAKEN BY AM

  Patient problems: Confusion/ Disorientation; Fever; Sepsis

  MAUDE report 15454386 ↗
• MalfunctionDec 1, 2021Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A TECHNICIAN REPORTED A PATIENT ISSUE WITH A CT LOWPROFILE SMARTPORT. POST PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS COMPLETELY EXPOSED OUTSIDE OF THE PATIENT'S SKIN. THE DEVICE WAS PLACED IN 2020 FOR CHEMOTHERAPY TREATMENT DUE TO CANCER DIAGNOSIS. THE PATIENT RETURNED FOR PORT REMOVAL IN (B)(6), AFTER THE DEVICE WAS FOUND TO BE EXPOSED. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Skin Erosion

  MAUDE report 12911777 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED A PATIENT ISSUE WITH A CT LOWPROFILE, WITH VALVE INTRODUCER, SMARTPORT. POST PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS COMPLETELY EXPOSED OUTSIDE OF THE PATIENT'S SKIN WHEN THE PATIENT ARRIVED FOR THE MONTHLY FLUSH. THERE WAS NO PRIMARY OR SECONDARY INFECTION. THE PATIENT HAD INDICATED A FEW WEEKS PRIOR THAT DURING A LONG TRIP, THE CAR SEAT BELT WAS OVER TOP OF THE PORT SITE AND IT WAS IRRITATING THE SITE. WHEN SHE LOOKED CLOSER, SHE NOTICED THE PORT HAD ERODED THROUGH THE SKIN. THE DEVICE HAD BEEN PLACED ON (B)(6) 2020 FOR CHEMOTHERAPY TREATMENT DUE TO CANCER DIAGNOSIS. THE PATIENT COMPLETED CHEMOTHERAPY IN (B)(6) 2021. THE PHYSICIAN LEARNED, A FEW DAYS AGO, THAT THE PATIENT'S SKIN OVER THE PORT WAS BLACK AND BLUE WHEN THE PATIENT PRESENTED TO HAVE THE PORT FLUSHED ON (B)(6) 2020, BUT THE INFUSION NURSES AND ONCOLOGIST CONTINUED TREATMENT AND DID NOT NOTIFY THE PHYSICIAN OF THIS. THE PHYSICIAN BECAME AWARE OF THIS ISSUE WHEN REQUESTED TO REMOVE THE DEVICE FROM THE PATIENT. AFTER PORT REMOVAL ON (B)(6) 2021, THE PATIENT WAS REPORTED AS BEING TREATED WITH ANTIBIOTICS AND AS DOING WELL. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFAC

  Patient problems: Skin Erosion

  MAUDE report 12086641 ↗
• MalfunctionMay 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AN END USER REPORTED ISSUES WITH CT LOWPROFILE WITH VALVED INTRODUCER, SMARTPORTS. ON 6-8 DIFFERENT OCCASIONS, THE PEELABLE SHEATH HAS BEEN BREAKING INTO PIECES WHEN THE INTRODUCER IS BROKEN APART, AFTER THE CATHETER HAS BEEN ADVANCED THROUGH. IT WAS REPORTED THAT THE WINGS REMAINED INTACT, THAT IT WAS THE ORANGE AND CLEAR PART OF THE INTRODUCER THAT BREAKS INTO 2 TO 4 PIECES. SOME PIECES FLY OFF THE STERILE FIELD AN LAND ON THE FLOOR, OTHER PIECES AROUND THE PORT SITE. THIS REQUIRES THE PHYSICIAN TO CAREFULLY REMOVE ALL THE PIECES TO ENSURE NONE ARE LEFT INSIDE OF THE PATIENT. THE PROCEDURES WERE COMPLETED SUCCESSFULLY AND THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THESE INCIDENTS. ALL OCCURRENCES HAVE HAPPENED WITHIN THE LAST MONTH, WITH THE SAME LOT NUMBER. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797336 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TECHNICIAN REPORTED AN ISSUE IN A PATIENTS WITH A CT LOW PROFILE WITH VALVED INTRODUCER SMARTPORT. POST PLACEMENT PROCEDURE, THE PATIENT WAS FOUND TO HAVE WOUND DEHISCENCE, PORT POCKET INFECTION, AND SKIN EROSION. THE PORT WAS REMOVED DUE TO THESE ISSUES, AND THE DOCTOR BELIEVES THE CAUSES ARE MULTIFACTORIAL, BUT CANNULATION TECHNIQUE IS LIKELY PLAYING A ROLE. THE CUSTOMER HAS RECENTLY INSTITUTED A PRE-PROCEDURE HIBICLENS PROTOCOL TO REDUCE THE RISK OF INFECTION; HOWEVER, THEY ARE NOT EXACTLY SURE WHAT IS CAUSING THIS AS IT'S NEVER HAPPENED THROUGHOUT THE YEARS. THE PHYSICIAN IS STILL LOOKING TO UNCOVER THE CAUSE AS IT'S THE SAME PORT, SAME PHYSICIAN AND PLACEMENT TECHNIQUE SINCE 2018. ADDITIONAL INFORMATION OBTAINED REPORTED THE CHEMO INFUSION FOR THE PATIENT IS PERFORMED BY AN INFUSION SERVICE AND NOT THE REPORTING CUSTOMER. THE CUSTOMER HAS INDICATED THEY WILL PROVIDE AN "IN-SERVICE" WITH THE NURSES AT THE REFERRING FACILITIES. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Post Operative Wound Infection; Skin Erosion; Wound Dehiscence

  MAUDE report 11648304 ↗
• MalfunctionAug 10, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AN END USER REPORTED THAT WHEN PREPPING FOR A PORT PLACEMENT PROCEDURE, 2 LOWPROFILE SMARTPORT DEVICES WERE NOTED TO HAVE "BROKEN STERILITY" AND COULD NOT BE USED. THE DEVICES WERE SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT AS IT OCCURRED DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. IT WAS INDICATED THE REPORTED DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387563 ↗