Vital-PortRecalls & reported problems across all models
Cook Incorporated · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 0
We found 11 models of Vital-Port by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2015 and Jan 7, 2020 — classified as 26 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Material Separation” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Vital-Port problems
Device problems
- Material Separation12
- Fracture4
- Break3
- Detachment Of Device Component3
- Detachment of Device or Device Component3
- Fluid/Blood Leak3
- Migration or Expulsion of Device3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Code Available19
- Device Embedded In Tissue or Plaque5
- Inflammation3
- No Known Impact Or Consequence To Patient3
- Failure of Implant2
- Foreign Body In Patient2
- Unspecified Infection2
- Atrial Perforation1
Vital-Port models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vital-Port G26489CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS12 reports
- Vital-Port G26511PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 reports
- Vital-Port G26438PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Vital-Port G26434PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Vital-Port G26440PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Vital-Port G26441PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Vital-Port G26449PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Vital-Port G26472CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Vital-Port G26504PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Vital-Port G26507PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Vital-Port G50860PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent Vital-Port adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 5, 2018Disconnection; Disconnection
IT WAS REPORTED THAT A VITAL-PORT INFUSION PORT WAS IMPLANTED IN THE PATIENT. A WEEK LATER, IT WAS DISCOVERED THAT THE CATHETER HAD DISCONNECTED FROM THE PORT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL THE NEXT DAY AND ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE DETACHED CATHETER. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 7314662 ↗InjuryJan 19, 2018Fracture; Fracture
IT WAS REPORTED THAT AN INFUSION PORT WAS IMPLANTED INTO THE PATIENT (B)(6) 2017. WHEN PATIENT CAME BACK TO THE HOSPITAL FOR TREATMENT, THE NURSING STAFF COULD NOT GET BLOOD RETURN UPON ACCESSING THE DEVICE. A SCAN WAS PERFORMED AND IT WAS DISCOVERED THAT THE PORT WAS CRACKED, CAUSING THE PATIENT TO UNDERGO AN ADDITIONAL PROCEDURE FOR THE SUCCESSFUL REINSERTION OF ANOTHER DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 7205288 ↗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 ↗InjuryNov 30, 2017Fracture; Fracture
THE CUSTOMER REPORTED THAT A PORT OF THE VITAL-PORT DETACHED SILICONE CATHETER HAD FRACTURED AND WAS NOT WORKING. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, IT WAS FOUND TO BE BROKEN IN PIECES. THE PORT WAS REMOVED IN THE OPERATING ROOM, BUT THE PATIENT WAS LATER TAKEN TO INTERVENTIONAL RADIOLOGY TO HAVE THE CATHETER REMOVED UNDER FLUOROSCOPY. THE PORT WAS PLACED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2017. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 7072142 ↗InjuryNov 29, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT, WHEN A PICTURE OF THE VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET DUAL TITANIUM INFUSION PORT WAS TAKEN UNDER FLUORESCENCE, A LEAK WAS DISCOVERED IN THE PORT. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER PRODUCT. THE LEAKING PORT WAS RETRIEVED WITH NO FURTHER ISSUES. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 7067042 ↗InjuryNov 10, 2017Break; Break
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT WAS ACCESSED WITH A GRIPPED NEEDLE AND FLUSHED WITH SALINE, THE PATIENT FELT PAIN AND DEVELOPED REDNESS AROUND THE PORT POCKET SITE. THE ACCOUNT REPORTEDLY ATTRIBUTED THE PAIN AND SWELLING TO THE DELIVERY OF THE SALINE INFUSION TO AN UNINTENDED LOCATION IN THE PATIENT'S ANATOMY. THE PATIENT WAS SENT TO RADIOLOGY FOR IMAGING, AND X-RAYS SHOWED THAT THE PORT HAD DETACHED AND THE CATHETER WAS BROKEN APPROXIMATELY 3 CM FROM THE PROXIMAL/PORT CHAMBER END. THE INTERVENTIONAL RADIOLOGIST RETRIEVED THE BROKEN CATHETER USING A SNARE, AS IT WAS SITTING JUST ABOVE THE PATIENT'S RIGHT ATRIUM. THE PORT WAS REMOVED AND RETURNED FOR EVALUATION. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Code Available; Pain; Swelling
MAUDE report 7022077 ↗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 ↗InjuryApr 7, 2017Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A VITAL-PORT ATTACHED SILICONE CATHETER WITH TITANIUM POWER INJECTABLE PORT IMPLANTED ON (B)(6) 2016 FOR CANCER TREATMENT. THE PATIENT IS A TENNIS PLAYER AND REPORTED DIFFICULTY IN FULLY EXTENDING HER ARM ABOVE HER HEAD TO SERVE AT TENNIS. THE PATIENT REPORTEDLY NOTICED IT EASIER TO MOVE HER ARM / SHOULDER THREE DAYS BEFORE THE PHYSICIAN NOTICED / DIAGNOSED THE CATHETER DAMAGE. THE PHYSICIAN OPINES POSSIBLE PINCH-OFF SYNDROME IN WHICH THE CATHETER IS COMPRESSED BETWEEN THE FIRST RIB AND THE CLAVICLE, CAUSING AN INTERMITTENT MECHANICAL OCCLUSION FOR BOTH INFUSION AND WITHDRAWAL. THE PORT WITH THE ATTACHED BROKEN CATHETER SEGMENT WAS REMOVED UNDER X-RAY GUIDANCE ON (B)(6) 2017. THE PROXIMAL END OF THE BROKEN CATHETER WAS OBSERVED REMAINING JUST BELOW THE LEVEL OF THE CLAVICLE DURING THE EXPLANT PROCEDURE. BEFORE THE PHYSICIAN WAS ABLE TO DETERMINE WHETHER OR NOT IT WAS FEASIBLE TO EXTRACT THIS VIA THE VENOUS TRACK THE NEXT IMAGE SHOWED THAT IT HAD THEN MIGRATED TO THE PATIENTS' ATRIUM. THE PATIENT WAS SENT FOR FRAGMENT REMOVAL FROM THE ATRIUM BY INTERVENTIONAL RADIOLOGY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 6472843 ↗MalfunctionFeb 15, 2017Material Separation; Material Separation
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A VITAL-PORT VASCULAR ACCESS SYSTEM IMPLANTED FOR AN UNSPECIFIED INDICATION. THE SPECIFIC SITE AND ROUTE OF IMPLANTATION WAS NOT PROVIDED. THE DEVICE ALLEGEDLY BROKE AT AN UNSPECIFIED TIME FOLLOWING IMPLANTATION. THE SIGNS, SYMPTOMS, CIRCUMSTANCES AND CONDITIONS THAT PROMPTED A RETURN OF THE PATIENT AND INDICATED A BREAK OF THE DEVICE WERE NOT PROVIDED. X-RAYS WERE TAKEN AND CONFIRMED THAT DEVICE BROKE / SEPARATED. THE PATIENT RETURNED TO THE HOSPITAL FOR EXPLANT OF THE PORT AND REMOVAL OF THE CATHETER FROM THE RIGHT ATRIUM. ONE OF THE PEDIATRIC PHYSICIANS WITH KNOWLEDGE OF THE EVENT PROVIDED ADDITIONAL DETAILS STATING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL UNDER THE PEDIATRIC CARDIOLOGY AND ADULT INTERVENTIONAL RADIOLOGY SERVICES. "THE TUBING AND THE DEVICE ITSELF WERE COMPLETELY SEPARATED AND THE TUBING HAD MIGRATED INTO THE PATIENT SO THAT THE TIP LAY IN THE RIGHT VENTRICLE. THIS POSED A RISK FOR CARDIAC ARRHYTHMIA AS WELL AS PULMONARY EMBOLUS." "THE PATIENT WAS NOT SYMPTOMATIC BUT WAS AT RISK OF A LIFE THREATENING COMPLICATION SHOULD AN ARRHYTHMIA OR EMBOLUS OCCUR. " THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CATHET
Patient problems: No Code Available
MAUDE report 6332169 ↗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 22, 2016Material Separation; Material Separation
PORT HAS BEEN IN PLACE FOR JUST UNDER 1 MONTH. PATIENT RETURNED FOR SECOND CHEMO TREATMENT AND STAFF COULD NOT ASPIRATE BLOOD. PATIENT SENT TO X-RAY AND FOUND THAT PORT CATHETER HAD SEPARATED/BROKEN TORN OFF JUST BELOW THE COLLAR, ACTUALLY ON THE CATHETER AND THE REMAINING CATHETER HAD TRAVELED INTO THE BLOOD SVC AND REQUIRED A FURTHER PROCEDURE IN THE HYBRID LAB TO REMOVE THE EMBOLIZED SILICONE PORT CATHETER. THIS WAS DONE VIA THE GROIN AS AN EMERGENCY PROCEDURE. PATIENT MISSED THEIR CHEMO DOSE AND HAD TO HAVE A LENGTHY ENDOVASCULAR RETRIEVAL PROCEDURE. THE DEVICE REMAINED INSIDE THE PATIENT BODY. THE PATIENT REQUIRED ANOTHER CVAD DEVICE TO BE PLACED SO PATIENT COULD GET TREATMENT DUE TO THIS OCCURRENCE. THE COMPLAINANT INFORMED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. HOWEVER, THE COMPLAINANT DOES NOT KNOW HOW THE CATHETER BROKE OFF INSIDE THE PATIENT. ONLY THAT IT DID.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 6200365 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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