XcelaRecalls & reported problems across all models
Navilyst Medical, Inc. · 39 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 39 models of Xcela by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2016 and Jun 3, 2026 — classified as 19 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Fracture” (20 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
Reports received per month, all models
Most reported Xcela problems
Device problems
- Fracture20
- Fluid/Blood Leak9
- Material Discolored9
- Infusion or Flow Problem7
- Detachment of Device or Device Component6
- Adverse Event Without Identified Device or Use Problem5
- Backflow3
- Crack3
Patient problems
- No Known Impact Or Consequence To Patient41
- No Clinical Signs, Symptoms or Conditions15
- Device Embedded In Tissue or Plaque4
- Foreign Body In Patient4
- Fluid Discharge3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bacterial Infection2
- Pain2
Xcela models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Xcela 60M701532Catheter,intravascular,therapeutic,long-term greater than 30 days10 reports
- Xcela 45671Catheter,intravascular,therapeutic,long-term greater than 30 days8 reports
- Xcela 45731Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- Xcela 25126Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- Xcela 45672Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- Xcela 25106Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- Xcela 44032PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Xcela H965451030PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Xcela 45668Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- Xcela H965451810PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Xcela H965451840PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Xcela 45733Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Xcela 55712Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Xcela 45652Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Xcela 60M033561Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- Xcela 25105Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 25123Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 25125Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 25129Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 44029PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Xcela 44031PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Xcela 44035PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Xcela 44041PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Xcela 45711Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 45712Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 45713Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 45715Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 45718Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 45732Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 55718Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 55731Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 55732Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 60M036762Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 60M163602Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 60M183104Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 60M194965Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 75001Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 45676Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Xcela 60M122272Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
Recent Xcela adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Appropriate Device Problem Term/Code Not Available
ON OR ABOUT (B)(6), 2016, PATIENT UNDERWENT PLACEMENT OF THE ANGIODYNAMICS XCELA POWER INJECTABLE PORT, LOT NUMBER 135896000, REFERENCE NUMBER H965451030. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6), COLORADO, FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6), 2017, PATIENT WAS PRESENTED TO (B)(6) HOSPITAL IN (B)(6), COLORADO WHERE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM. THE PORT WAS LATER REMOVED ON (B)(6), 2018 AT THE SAME HOSPITAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25382313 ↗InjuryJul 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON OR ABOUT (B)(6) 2013, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA POWER INJECTABLE PORT CATHETER PRODUCT, MODEL NUMBER H965451030, LOT NUMBER 121584000. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D.(B)(6) HOSPITAL IN (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING VENOUS ACCESS. ON OR ABOUT (B)(6) 2013, PATIENT PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF A REDNESS, TENDERNESS, AND PAIN OVER THE LEFT CHEST, SHOULDER, AND NECK AREA. PATIENT'S MEDICAL TEAM DETERMINED THAT HE HAD DEVELOPED AN INFECTION. ON OR ABOUT (B)(6) 2013, PATIENT'S INFECTED PORT WAS REMOVED BY DR. (B)(6), M.D., (B)(6) HOSPITAL. AT NO POINT DID PATIENT'S HEALTHCARE TEAM INDICATE TO HIM THAT THE XCELA FAILED OR WAS DEFECTIVE. PATIENT'S HEALTHCARE PROVIDERS DID NOT STATE THAT THE XCELA WAS THE CAUSE OF THE INFECTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22671548 ↗MalfunctionApr 17, 2025Fracture; Fracture
ADDITIONAL INFORMATION: A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM AN. ATO XCELA PASV 5F SL 55CM IR-145 KIT. THE LINE WAS INSERTED IN (B)(6) 2023, UNEVENTFUL, NO ISSUE. LINE CARE (FLUSHING, DRESSING) UNTIL DAY OF INCIDENT ((B)(6) 2025) AS PER INSTITUTION PROTOCOL, UNEVENTFUL, NO ISSUE. ON (B)(6) 2025, A NEW NEUTRON CONNECTOR WAS APPLIED, AND THERE WAS NO ISSUE. ON (B)(6) 2025, PRIOR TO COMMENCING CHEMOTHERAPY: GOOD BACKFLOW, NIL RESISTANCE TO FLUSHING WAS NOTED ON PICC LINE ASSESSMENT, NO ISSUE. A VISUAL ASSESSMENT OF THE PICC LINE WAS DOCUMENTED AS CLEAN, DRY, INTACT. ON (B)(6) 2025, THE NEUTRON CONNECTOR WAS DUE FOR CHANGE WITH PUMP REMOVAL AS PER PROTOCOL. THE NURSE WAS UNABLE TO REMOVE THE NEUTRON AFTER 2 ATTEMPTS. THIS WAS DONE IN A SEATED POSITION, WITH CONNECTOR TURNED IN AN ANTI-CLOCKWISE MANNER. THE NURSE ESCALATED IT TO A COLLEAGUE TO ASSIST, WHO WAS UNABLE TO REMOVE CONNECTOR BY HAND IN AN ANTI-CLOCKWISE MANNER. THE NURSE THEN USED A GAUZE TO WRAP AROUND THE NEUTRON TO FACILITATE ITS REMOVAL, WHICH SHE WAS ABLE TO ACCOMPLISH WITH EASE IN AN ANTI-CLOCKWISE FASHION. DURING THE REMOVAL PROCESS, NO SOUND OR ABNORMAL MOTION WAS NOT
Patient problems: Foreign Body In Patient
MAUDE report 21858352 ↗InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT ON (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX IMPLANTABLE PORT, MODEL NUMBER: H787P5455K0, LOT NUMBER: 5670753. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), TO FACILITATE CHEMOTHERAPY TREATMENT. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF A FEVER. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF RECEIVED A CALL FROM HER DOCTOR THAT HER BLOOD CULTURES DRAWN ON (B)(6) 2023, CAME BACK POSITIVE FOR A BACTERIAL INFECTION, AND THAT SHE NEEDS TO GO TO THE EMERGENCY ROOM. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED TO THE EMERGENCY ROOM AT (B)(6), FOR FURTHER EVALUATION AS DIRECTED BY HER DOCTOR. AFTER EVALUATION, PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE VORTEX WAS THE SOURCE OF THE INFECTION AND THAT THE IMPLANT NEEDED TO BE REMOVED. ON OR ABOUT ON (B)(6) 2023, DUE TO HER INFECTED VORTEX PORT CATHETER, PLAINTIFF UNDERWENT SURGICAL REMOVAL OF THE DEFECTIVE DEVICE, WHICH WAS REMOVED BY (B)(6), M.D., AT (B)(6).
Patient problems: Bacterial Infection; Fever
MAUDE report 21560507 ↗InjuryMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5737583. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO MALFUNCTIONING AND AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21559745 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, REFERENCE NUMBER H965440350, LOT NUMBER 5767870. THE DEVICE WAS IMPLANTED BY (B)(6) MD, AT (B)(6), FOR CHEMOTHERAPY ADMINISTRATION. ON OR ABOUT JULY 23, 2023, PLAINTIFF PRESENTED TO (B)(6) WITH CHEST PAINS AND WAS ADMITTED AFTER BLOOD CULTURES SHOWED GRAM POSITIVE COCCI AND STREPTOCOCCUS AGALACTIAE. HIS PHYSICIANS DETERMINED THE SOURCE OF THE INFECTION WAS THE XCELA PORT AND REQUIRED REMOVAL. ON OR ABOUT(B)(6) 2023 PLAINTIFF'S INFECTED PORT WAS REMOVED BY DR. (B)(6) MD AT (B)(6). AS A RESULT OF HAVING THE XCELA IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.
Patient problems: Bacterial Infection; Chest Pain
MAUDE report 20493597 ↗MalfunctionOct 9, 2024Fracture; Fracture
A SPECTRUM MEDICAL TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH AN XCELA 4FSL-55CM MAXIMAL BARRIER NURSING KIT . THE FOLLOWING WAS REPORTED: "SINGLE LUMEN PICC INSERTED 8/27/24 FOR VANCOMYCIN ADMINISTRATION. RIGHT UPPER ARM BASILIC VEIN USED, VESSEL DIAM 3.1MM, CVR APPROX 42%, INSERTION UNCOMPLICATED AND 1 ATTEMPT. CATHETER PERFORMED WITHOUT ISSUE FOR DURATION OF THERAPY. UPON REMOVAL OF CATHETER, RN EXPERIENCED SIGNIFICANT RESISTANCE. SURGEON WAS CONTACTED. APPROX AN HOUR WAS WAITED UNTIL NEXT REMOVAL ATTEMPT. NO WARM PACKS WERE TRIED. NO ANTI-ANXIETY MEDS WERE GIVEN. THE SURGEON TRIED AND EXPERIENCED THE SAME FINDING: SEVERE RESISTANCE. TOOK THE PATIENT TO A PROCEDURE ROOM FOR REMOVAL USING LIVE ULTRASOUND, FLUOROSCOPY, AND A 0.018 GUIDEWIRE. CATHETER WAS EVENTUALLY REMOVED (SNAPPED IN TWO DUE TO ALL THE PULLING AND RESISTANCE). ENTIRE CATHETER WAS RETRIEVED/REMOVED. CATHETER REMOVED WITH SIGNIFICANT RESISTANCE THE ENTIRE LENGTH OF THE VEIN. NO CLOT OBSERVED, CATHETER LUMEN OPEN/PATENT, NO KINKS OBSERVED ON ULTRASOUND OR FLURO. PT HAD A VENOGRAM POST PROCEDURE AND IT WAS NORMAL. IT WAS EITHER COMPLETED RIGHT AFTER THE PROCEDURE AND/OR APPROX 1 WEEK POST REMOVA
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20407382 ↗MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
AN END USER REPORTED AN ISSUE WITH AN XCELA, 8F SINGLE PLASTIC PORT FILLED NON-VALVED. DURING CHEMOTHERAPY TREATMENT, THE PORT WAS INFILTRATED AND LEAKED WITHIN THE PATIENT. THE PATIENT HAD A PORT REMOVAL PROCEDURE SCHEDULED FOR (B)(6) 2024. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL DETAILS, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Infiltration into Tissue
MAUDE report 19762788 ↗MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A DIRECTOR OF CARDIAC AND VASCULAR SERVICES REPORTED AN ISSUE WITH AN XCELA 5FDL-55CM IR-145 KIT. DURING PLACEMENT OF THE CATHETER, THE PEEL AWAY SHEATH BROKE AWAY FROM THE SHEATH HUB AS THE PICC WAS BEING ADVANCED OVER THE GUIDEWIRE. THE SHEATH BECAME LODGED IN THE PATIENT'S BODY BUT WAS ABLE TO BE RETRIEVED USING A SNARE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 19701499 ↗MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN XCELA, 8F SINGLE PLASTIC PORT NON-FILLED NON-VALVED. DURING A PROCEDURE, THE .035 GUIDEWIRE BECAME STUCK IN THE 18 GAUGE INTRODUCER NEEDLE AND COULD NOT BE REMOVED. THE PHYSICIAN DID REPORT PULLING THE GUIDEWIRE BACK THROUGH THE NEEDLE, DURING THE PROCEDURE ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. DURING EVALUATION OF THE RETURNED SAMPLE, THE GUIDEWIRE WAS FOUND TO BE DETACHED, INSIDE OF THE NEEDLE LUMEN. FOLLOW UP DETERMINED THAT THE GUIDEWIRE FRACTURE OCCURRED WHILE PLACED INSIDE OF THE NEEDLE, IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19060625 ↗MalfunctionDec 4, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A GUIDEWIRE FROM A XCELA 5FDL-55CM IR-145 KIT. DURING THE PROCEDURE, A 0.018 INCH GUIDE WIRE WAS INSERTED INTO THE BODY AND A PICC CATHETER WAS INSERTED. WHEN TRYING TO REMOVE THE GUIDEWIRE, IT DID NOT COME OUT, SO THEY PULLED ON THE GUIDE WIRE AND THE TIP OF THE GUIDEWIRE BROKE. A SECOND KIT WAS OPENED, AND THE 0.018 INCH GUIDE WIRE WAS INSERTED INTO THE BODY AND A PICC CATHETER WAS INSERTED. WHEN TRYING TO REMOVE THE GUIDE WIRE, IT WOULD NOT COME OUT. THEY REMOVED THE PICC CATHETER AND GUIDEWIRE AS ONE UNIT DUE TO CONCERNS ABOUT THE SAME SYMPTOMS AS ABOVE OCCURRING. IT WAS REPORTED THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18256665 ↗MalfunctionMay 9, 2023Particulates; Particulates
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM AN XCELA PASV 5F KIT. THE PICC HAD BEEN IN USE FOR 28 DAYS PRIOR TO THE REPORTED EVENT FOR A STEM CELL TRANSPLANT. WHILE DRAWING BLOOD, WHITE PARTICLES WERE NOTED IN THE DISPOSABLE SYRINGE, COMING FROM BOTH LUMENS. THE CATHETER WAS REMOVED. DUE TO THIS EVENT, THE PATIENT NEEDED A NEW PICC INSERTED, AND THE STEM CELL TRANSPLANT WAS DELAYED. THE FREQUENCY OF THE PICC USE BEFORE THIS EVENT WAS REPORTED AS INTERMITTENT FOR HYDRATION, MEDICATIONS, AND POTENTIAL BLOOD PRODUCTS. THE PARTICLES NOTED BY STAFF WERE NOT SUBMITTED FOR ANALYSIS BY THE FACILITY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16895771 ↗MalfunctionMay 9, 2023Particulates; Particulates
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM AN XCELA PASV 5F DL 55CM MST-70 KIT. THE PICC HAD BEEN PLACED 7 DAYS PRIOR TO THE REPORTED EVENT FOR A STEM CELL TRANSPLANT THAT HAD YET TO BE PERFORMED. WHILE DRAWING BLOOD, WHITE PARTICLES WERE NOTED IN THE DISPOSABLE SYRINGE, COMING FROM BOTH LUMENS. THE PICC WAS PREVIOUSLY USED ONLY FOR HYDRATION AND FLUSHING/LOCKING FOR MAINTENANCE. THE CATHETER WAS REMOVED AND NEW CATHETER WILL NEED TO BE INSERTED. DUE TO THIS EVENT, THE STEM CELL TRANSPLANT WAS DELAYED UNTIL THE NEW PICC IS PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16895197 ↗MalfunctionSep 15, 2021Material Discolored; Material Discolored
AN END USER REPORTED AN ISSUE WITH A CAN 5F DUAL XCELA PICC. IT WAS REPORTED THAT, DURING VISUAL INSPECTION, ONE LUMEN OF THE PICC WAS NOTED TO BE CLOUDY YELLOW. THERE IS ALSO A "HOMOGENOUS CLOUDINESS" THROUGHOUT THE VISIBLE PORTION OF THE CATHETER. THE PICC WAS IN SITU FOR APPROXIMATELY 8 MONTHS BEFORE IT WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12475954 ↗MalfunctionAug 31, 2021Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH A XCELA PASV 5F SL 55CM IR-145 KIT. A DAY AFTER THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE HAD DISLODGED INTO THE PATIENT'S MID-HUMERUS. THIS WAS ONLY NOTICED ONCE THE PATIENT RETURN TO A DIFFERENT HOSPITAL FOR A CHECK AND HAD AN ULTRASOUND PERFORMED. THE PIECE OF GUIDEWIRE WAS REMOVED THROUGH THE SAME ENTRY POINT; THEREFORE, SURGERY WAS NOT REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 12391825 ↗
Other Navilyst Medical, Inc. products
All Navilyst Medical, Inc. 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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