Vital-Port G26489Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002264892), received between Mar 1, 2016 and Jan 7, 2020 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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.

• MalfunctionJan 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED A COOK VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT (IP-S5116W-MPIS-NT) SHOWED EXTRAVASATION AND A CATHETER DEFECT WITH LEAKAGE. AS A RESULT, THE CHAMBER AND THE CATHETER HAD TO BE REMOVED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Extravasation

  MAUDE report 9559831 ↗
• MalfunctionDec 11, 2019Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A COOK VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT (IP-S5116W-MPIS-NT) COULD NOT BE FLUSHED, NO WITHDRAWING POSSIBLE. THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IS SHOWED A TORN OFF CATHETER AND A LEAKAGE WITHIN THE REMAINING CATHETER PART, CLOSE TO THE PORT CHAMBER. THE PORT AND CATHETER WERE EXPLANTED / REMOVED, NO SECTION OF THE DEVICE REMAINED IN THE PATIENT. IT WAS ALSO NOTED THAT NO PRODUCT IS AVAILABLE FOR EXAMINATION BY MANUFACTURER.

  Patient problems: No Code Available

  MAUDE report 9454196 ↗
• InjuryMay 16, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  THE VITAL-PORT VASCULAR ACCESS SYSTEM WAS IMPLANTED ON (B)(6) 2017. A MID-CATHETER LEAK WAS DETECTED ON (B)(6) 2018. THE CATHETER DETACHED COMPLETELY AND HAD TO BE REMOVED FROM PULMONARY ARTERY ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7517898 ↗
• InjuryApr 23, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  AN EX PLANTATION PROCEDURE REVEALED THAT A 15 CM SECTION OF THE CATHETER SEPARATED FROM THE PORT BODY AND WAS SHOWN TO BE MISSING. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY AS AN X-RAY SHOWED IT WAS STILL IN THE VASCULAR SYSTEM AT THE HEART. AN ADDITIONAL PROCEDURE FOR RETRIEVAL OF THIS PIECE WAS SCHEDULED FOR THE (B)(6) APRIL. PER INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7450480 ↗
• InjuryJan 4, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT HAD AN INFUSION PORT IMPLANTED ON (B)(6) 2017. WHEN THE PATIENT RETURNED THREE WEEKS POST-OP FOR TREATMENT, THE NURSES WERE UNABLE TO GET BLOOD RETURN AND SENT THE PATIENT FOR A PORTOGRAM. THE PORTOGRAM SHOWED THAT THE CATHETER HAD SEPARATED FROM THE PORT HUB AND WAS IN THE PULMONARY ARTERY. SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE PIECE AND WAS SUCCESSFULLY COMPLETED ON (B)(6) 2017. THE MANUFACTURER WAS NOT INFORMED OF EVENT UNTIL 06DEC2017. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7164987 ↗
• InjuryJul 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

  Patient problems: Inflammation

  MAUDE report 6684024 ↗
• InjuryJan 12, 2017Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  DURING A BRACHIAL VITAL PORT INSERTION ON A FEMALE PATIENT, IT WAS IMPOSSIBLE TO CONNECT THE CATHETER TO THE PORT SAFELY AS PREVIOUSLY THERE WAS A PROBLEM OF DISCONNECTION, AND THE CATHETER MIGRATED. THE RADIOLOGIST RETRIEVED THE DEVICE WITH ENDOVASCULAR FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6246066 ↗
• InjuryDec 14, 2016Material Separation; Material Separation

  IT WAS REPORTED THE CHAMBER AND CATHETER WERE SEPARATED INSIDE THE PATIENT'S BODY AFTER ONE DAY OF THE PROCEDURE. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REPLACE THE DEVICE WITH A NEW ONE ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 6173906 ↗
• InjuryOct 11, 2016Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD COMPLICATIONS FROM A VITAL PORT VASCULAR ACCESS SYSTEM PLACED ON (B)(6) 2016 IN THE PERIPHERAL VEIN. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2016 DUE TO A CATHETER THAT SHEARED, RESULTING IN AN EMBOLIZATION OF THE DISTAL PART CAUSING A CEREBRAL STROKE. IT WAS NOTED THE BROKEN MINIPORT CATHETER HAD ABOUT A 15CM CONNECTED TO THE CHAMBER AND THE REST HAD MIGRATED TOWARDS THE HEART FROM THE SUPERIOR VENA CAVA INTO THE RIGHT ATRIUM. A PERFORATION OF UNCLEAR ORIGIN WAS NOTED AND MIGRATION INTO THE LEFT ATRIUM, WITH THE TIP HEADED TO THE LEFT VENTRICLE WHERE IT GOT STUCK IN THE AORTIC VALVE. THE PHYSICIAN REPORTEDLY DETERMINED THE CEREBRAL STROKE WAS CAUSED BY THROMBUS ORIGINATING FROM THE MIGRATED CATHETER TIP IN THE AORTIC VALVE AND THAT THE THROMBUS TRAVELED UP TO THE HEAD/BRAIN AREA. THE CATHETER AND CATHETER TIP WERE RETRIEVED BY THE RADIOLOGY DEPARTMENT, THE VITAL PORT WAS EXPLANTED AND THE CEREBRAL THROMBUS WAS RESOLVED.THE PATIENT IS REPORTED TO HAVE "RECOVERED QUITE WELL FROM THE CEREBRAL STROKE." THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Atrial Perforation; Embolism; Stroke/CVA

  MAUDE report 6016314 ↗
• InjurySep 2, 2016Material Separation; Material Separation

  DURING THE FLUSHING THE VITAL PORT CATHETER WITH THE SYRINGE, THE PRESSURE CAUSED THE CATHETER TO SEPARATE AND REMAIN IN THE PATIENT'S BODY. THE DEVICE WAS EXPLANTED AND THE CATHETER WAS REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTER THIS OCCURRENCE

  Patient problems: No Code Available

  MAUDE report 5924703 ↗
• InjuryMay 19, 2016Material Separation; Material Separation

  A MINI PORT PLACEMENT WAS PERFORMED ON (B)(6) 2014 ON A FEMALE PATIENT WHO HAD THE PRE-EXISTING CONDITION OF BREAST CANCER. THERE WAS CATHETER MIGRATION AFTER A RUPTURE OF THE CATHETER PROXIMALLY 10 CM AFTER THE CONNECTION WITH THE RESERVOIR. THE USER FACILITY REMOVED THE CATHETER AND MINI PORT ON (B)(6) 2016. THE PIECE OF THE CATHETER THAT HAD MIGRATED WAS REMOVED UNDER FLUOROSCOPY. THE USER FACILITY REMOVED THE CATHETER AND MINI PORT ON (B)(6) 2016. THE PIECE OF THE CATHETER THAT HAD MIGRATED WAS REMOVED UNDER FLUOROSCOPY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5666053 ↗
• InjuryMar 1, 2016Material Separation; Material Separation

  THE RECENTLY PLACED PORT CATHETER WAS FOUND TO BE FRACTURED APPROXIMATELY 10CM FROM THE PORT OUTLET WITHIN THE FEMALE PATIENT. THE END PORTION DETACHED COMPLETELY AND HAD TO BE SNARED. ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER: THE PATIENT HAS BEEN UNWELL AND THE CONSULTANT WAS AWAY SO THE PORT AND REMAINDER OF CATHETER HAD NOT YET BEEN REMOVED. THE PORT AND CATHETER HAD BEEN APPROXIMATELY PLACED IN THE PATIENT FOR 2 WEEKS UNTIL IT WAS COMPLETELY REMOVED.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 5470697 ↗