Vortex LVTX5213Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI H787LVTX52130), received between Jan 12, 2017 and Apr 26, 2026 — classified as 21 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K010767); they may or may not involve this specific model.

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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6), 2023, PLAINTIFF UNDERWENT REMOVAL AND REPLACEMENT OF THE ANGIO DYNAMICS SMARTPORT DUAL LUMEN VORTEX PORT. ON (B)(6), 2024 THE PLAINTIFF RETURNED TO (B)(6) HOSPITAL COMPLAINING THAT THE PORT SITE WAS LEAKING AND PAINFUL. INSERTION OF A "RIGHT VORTEX CHEST PORT", AN ANGIO DYNAMICS VORTEX PORT, REF (B)(4) WAS THEN PERFORMED.

  Patient problems: Fluid Discharge; Implant Pain

  MAUDE report 24993511 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER, WITH MODEL NUMBER LVTX5213, AND LOT NUMBER 4993087. THE VORTEX DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE VORTEX DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR THE PURPOSE OF TREATING PLAINTIFF'S PLASMAPHERESIS. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6). BLOOD CULTURES WERE DRAWN AND RETURNED POSITIVE FOR INFECTION, NECESSITATING REMOVAL OF THE DEVICE. ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE DEVICE. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6).

  Patient problems: Bacterial Infection

  MAUDE report 24635045 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER, WITH LOT NUMBER 4909401. THE VORTEX DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF TREATING PLAINTIFF'S PLASMAPHERESIS. ON OR ABOUT (B)(6) 2017, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6) WITH EROSION OF HER PORT. ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT REPLACEMENT OF HER ANGIODYNAMICS VORTEX PORT CATHETER.

  Patient problems: Pocket Erosion

  MAUDE report 24635044 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, DECEDENT (B)(6) UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX DUAL LUMEN TITANIUM PORT CATHETER PRODUCT, WITH PRODUCT CODE H787LVTX52130, AND LOT NUMBER 5723798. THE VORTEX WAS IMPLANTED BY DR. (B)(6), M.D. AT (B)(6) HOSPITAL IN (B)(6) FOR THE PURPOSE OF ADMINISTERING PHOTOPHERESIS TO TREAT PLAINTIFF'S MYCOSIS FUNGOIDES SYNDROMES, A TYPE OF CUTANEOUS T-CELL LYMPHOMA. ON OR ABOUT (B)(6) 2024, DECEDENT PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH SYMPTOMS OF AN INFECTION. BLOOD CULTURES WERE DRAWN FROM THE PORT SITE AND CAME BACK POSITIVE FOR BACTEREMIA, AND DECEDENT WAS SUBSEQUENTLY DIAGNOSED WITH SEPSIS AND ADMITTED TO ASPIRUS FOR TREATMENT AND PLANNED REMOVAL OF THE VORTEX. ON OR ABOUT (B)(6) 2024, WHILE STILL HOSPITALIZED AT (B)(6) HOSPITAL, DECEDENT UNDERWENT REMOVAL OF THE VORTEX DEVICE, AND THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), D.O. FOLLOWING REMOVAL OF THE VORTEX, DECEDENT REMAINED HOSPITALIZED FOR CONTINUED TREATMENT AND WAS DISCHARGED ON OR ABOUT (B)(6) 2024. UPON DISCHARGE FROM (B)(6) HOSPITAL ON OR ABOUT (B)(6) 2024, DECEDENT WAS INSTRUCTED TO CONTINUE TAKING ANTIBIOTICS ON A LONG-TERM BASIS. DECEDENT CONTINUED TAKING ANTIBIOTICS UNTIL PA

  Patient problems: Bacteremia; Sepsis

  MAUDE report 24317586 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT A PATIENT'S LP TITANIUM VTX 12 FR DET 12F INTRO PG BECAME INFECTED. DESPITE ANTIBIOTIC TREATMENT, THE INFECTION DID NOT RESOLVE; THEREFORE, THE PORT WAS REMOVED AND REPLACED WITH ANOTHER PORT. DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS WERE OBTAINED.

  Patient problems: Bacterial Infection

  MAUDE report 23597004 ↗
• MalfunctionMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OR ABOUT (B)(6) 2011, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PRODUCT, REFERENCE NUMBER LVTX5213. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) IN (B)(6) , FOR THE PURPOSE OF ONGOING VEIN ACCESS, DUE TO SICKLE CELL DISEASE. ON OR ABOUT (B)(6) 2018, PLAINTIFF'S PORT WAS, ALLEGEDLY, DEFECTIVE AND WAS REMOVED BY DR. (B)(6), M.D., (B)(6) HOSPITAL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559422 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, E.H. UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' VORTEX LP PRODUCT, UPN (B)(4), LOT NUMBER 5400308. UPON INFORMATION AND BELIEF, THE VORTEX LP DEVICE AT ISSUE HAS THE FOLLOWING DESCRIPTION: VORTEX LP DUAL TITANIUM PORT SYSTEM WITH ATTACHABLE 11.4F X 76CM SILICONE CATHETER. THE VORTEX LP DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6) LOUISIANA, FOR TRANSFUSION TREATMENT FOR PLAINTIFF'S SICKLE CELL ANEMIA. ON OR ABOUT DECEMBER 14, 2022, PLAINTIFF PRESENTED TO (B)(6) LOUISIANA, TO BE EVALUATED FOR PAIN CRISIS RELATED TO HER SICKLE CELL ANEMIA; AT THAT TIME, E.H.'S MEDICAL TEAM FOUND HER TO BE PERSISTENTLY BACTEREMIC WITH STAPH EPIDERMITIS. AT THAT TIME, PLAINTIFF'S MEDICAL TEAM INVESTIGATED THE POSSIBLE SOURCES OF PLAINTIFF'S PERSISTENT BACTEREMIA. THE INFECTIOUS DISEASE SERVICE BECAME INVOLVED IN THE PROCESS OF SAID INVESTIGATION AND IT WAS ABLE TO DETERMINE THAT PLAINTIFF'S PORT, I.E., HER VORTEX LP PORT, WAS THE SOURCE OF HER PERSISTENT BACTEREMIA WITH STAPH EPIDERMIDIS. ON (B)(6) 2022, PLAINTIFF'S INFECTED PORT, I.E., THE SOURCE OF PLAINTIFF'S PERSISTENT BACTEREMIA WITH STAPH EPIDERMIDIS, WAS REMOVED BY DR. (B)(6) MD, AT TULANE MEDICAL CENTER. AS A

  Patient problems: Bacteremia

  MAUDE report 20416813 ↗
• MalfunctionJun 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5712823. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN ATLANTA, GEORGIA, FOR THE PURPOSE OF PROVIDING TRANSFUSION EXCHANGES FOR SICKLE CELL DISEASE. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN LITHONIA, GEORGIA FOR REMOVAL AND REPLACEMENT OF HIS MALFUNCTIONING PORT. A PORTY STUDY WAS CONDUCTED THAT DEMONSTRATED EXTRAVASATION AROUND THE PORT CONNECTOR. THE DEFECTIVE DEVICE WAS REPLACED WITH A BARD POWERPORT. AS A RESULT OF HAVING THE VORTEX IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Discomfort; Failure of Implant; Infiltration into Tissue

  MAUDE report 19567665 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (PORT 1) ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PRODUCT AT UNIVERSITY OF IOWA. THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING RED CELL EXCHANGES AND VEIN ACCESS. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6) WITH COMPLAINTS OF PLEURITIC CHEST WALL PAIN. PLAINTIFF WAS ALSO FOUND TO BE FEBRILE AND THEREFORE WAS TRANSFERRED TO MARY GREELEY MEDICAL CENTER IN AMES, IOWA. UPON BEING ADMITTED AT (B)(6) MEDICAL CENTER, PLAINTIFF'S BLOOD CULTURES WERE DRAWN AND WERE PERSISTENTLY POSITIVE. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE VORTEX WAS THE SOURCE OF THE INFECTION AND THAT THE DEFECTIVE PORT HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2022, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6) . (PORT 2) ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ADDITIONAL ANGIODYNAMICS VORTEX PRODUCT, REFERENCE NUMBER LVTX5213, LOT NUMBER 5730316. THE DEVICE WAS IMPLANTED BY (B)(6) , M.D., AT (B)(6) IN (B)(6) , FOR ONGOING RED CELL EXCHANGES AND VEIN ACCESS. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR STAPH AUREUS. PLAINT

  Patient problems: Bacterial Infection

  MAUDE report 19153521 ↗
• InjuryAug 29, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN END-USER FACILITY'S PEDIATRIC CLINICAL NURSE SPECIALIST REPORTED THAT A LP TITANIUM VORTEX PORT HAD BEEN INSERTED INTO A 9-YEAR-OLD MALE PATIENT IN (B)(6) 2023. A FEW WEEKS LATER WHEN IT WAS ACCESSED FOR THE FIRST TIME, BLEED BACK WAS NOT ABLE TO BE PERFORMED. FOLLOWING AN X-RAY AND CT ANGIOGRAM IT WAS DISCOVERED THAT THE LINE HAD BECOME DETACHED FROM THE HUB. THE LINE HAD MIGRATED THROUGH THE PATIENT'S HEART, AND IT'S TIP WAS PROJECTED IN THE LEFT MAIN PULMONARY ARTERY. THE PATIENT WAS TRANSFERRED TO A CARDIOLOGY SPECIALIST TEAM, AT A DIFFERENT SPECIALIST HOSPITAL, WHERE THE LINE PART WAS REMOVED UNDER CARDIOLOGICAL RADIOLOGICAL GUIDANCE; THE LINE PART OF THE PORT WAS DISCARDED FOLLOWING THE REMOVAL PROCEDURE. ADDITIONALLY, AT A LATER DATE, THE PATIENT HAD THE HUB PART OF THE PORT REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 17640879 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN  IR TECH MANAGER REPORTED AN ISSUE WITH A LP TITANIUM VTX 12 FR DET 12F INTRO PORT. DURING A PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED AN AIR EMBOLISM, UPON REMOVAL OF THE WIRE AND DILATOR, PRIOR TO INSERTION OF THE CATHETER. THE PATIENT WAS STABILIZED AND THE AIR EMBOLISM RESOLVED BY THE TIME THE INTERVENTIONIST INTERVENED. THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE PROVIDER HAD DETERMINED AFTER THE EMBOLISM OCCURRED THAT THEY SHOULD HAVE USED A VALVED SHEATH, AND NOT THE NON-VALVED.

  Patient problems: Air Embolism

  MAUDE report 15995993 ↗
• MalfunctionJan 14, 2022Infusion or Flow Problem; Infusion or Flow Problem

  AN END USER REPORTED AN EVENT THAT OCCURRED WITH A LP TITANIUM VTX 12 FR DET 12F INTRO PORT. THE PATIENT HAD SIGNIFICANT ACCESS ISSUES WITH HIS PORT. HIS LATERAL PORT WAS ACCESSED, FLUSHED AND PULLED WITH NO ISSUE. THE MEDIAL PORT WOULD NOT FLUSH OR DRAW. A CONTRAST STUDY UNDER FLOURO WAS PERFORMED WHICH SHOWED A RETAINED CATHETER FRAGMENT IN THE DISTRIBUTION OF THE LEFT BRACHIOCEPHALIC VEIN LEFT FROM A PREVIOUSLY REMOVED UNKNOWN PORT. UNDER FLOURO, THEY ATTEMPTED TO INFUSE CONTRAST, HOWEVER ONLY A SHORT SEGMENT OF THE EXTERNAL CATHETER ASSOCIATED WITH THE ACCESS NEEDLE FILLED WITH CONTRAST MATERIAL, AFTER WHICH RESISTANCE PRECLUDED A CONTRAST EXTENDING MORE DISTALLY INTO THE HUB ITSELF. AFTER DOCUMENTING THIS, THE EXAMINATION WAS TERMINATED. THE PATIENT WAS RETURNED TO HIS ROOM, AND A NP PERFORMED ARBCX WITH THE LATERAL PORT OUT OF THE PATIENT AND PERIPHERAL ACCESS INTO THE PATIENT. THE PATIENT WAS DISCHARGED HOME WITH USAGE INSTRUCTIONS. THE PATIENT HAS BEEN SCHEDULED FOR (B)(6) 2022 FOR REMOVAL AND REPLACEMENT AS THE PATIENT REQUIRES BOTH HUBS TO BE FUNCTIONAL FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257977 ↗
• InjuryAug 26, 2019Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  AS REPORTED: DUAL LUMEN VOTEX PORT INSERTED ON (B)(6) 2019. ON (B)(6) IT WAS DISCOVERED THAT THE CATHETER HAD BECOME DISCONNECTED FROM THE SEPTUM. PORT WAS EVALUATED DUE TO COMPLAINTS OF A LARGE HEMATOMA AND PAIN BY THE PATIENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Burning Sensation; Hematoma

  MAUDE report 8932206 ↗
• InjuryAug 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED: DUAL LUMEN VORTEX PORT BEING USED FOR APHERESIS FOR PRBC EXCHANGE. NOTED OVER A PERIOD OF APPROXIMATELY 3 PROCEDURES, THAT HEMOGLOBIN S WAS NOT DROPPING AS EXPECTED. RADIOGRAPHIC EVALUATION OF PORT WAS DONE AFTER THE SECOND UNSUCCESSFUL APHERESIS TREATMENT, AND AS RELATED BY THE SITE, THE DYE STUDY SHOWED PATENCY WITH DYE COMING OUT OF EACH CATHETER TIP WITH NO APPARENT FIBRIN SHEATH. TODAY, (B)(6) 2019, THE PATIENT WAS ONCE AGAIN SENT FOR EVALUATION OF THE PORT IN IR. I (ANGIODYNAMICS REPRESENTATIVE) WAS CALLED BY THE FACILITY TO FACILITATE THE RETURN OF THE PORT IF IT BECAME EXPLANTED. ACCORDING TO THE APHERESIS NURSE, WHO WAS IN THE IR CASE, THERE WAS NOT A SIGNIFICANT FIBRIN SHEATH ON SNARING ATTEMPT. ALSO, CONTRAST INJECTED SEEMED TO TERMINATE AT THE SAME LOCATION PER LUMEN, DESPITE THE STAGGERED TIP OF THE CATHETER. ONE CHAMBER OF THE PORT ALSO DID NOT FILL COMPLETELY WITH CONTRAST MEDIA ON INJECTION. THE PORT WAS EXPLANTED, AND RESERVED FOR RETURN IN BIOHAZARD BAG. THE PATIENT THEN WENT TO OR FOR PLACEMENT OF A NEW DUAL LUMEN VORTEX PORT. POST EXPLANT INSPECTION BY THE SITE WAS DONE USING A BLUNT TIP CATHETER TO FLUSH EACH LUMEN OF THE CUT CATHETER. IT WAS NOTED

  Patient problems: Apheresis; Device Embedded In Tissue or Plaque

  MAUDE report 8893024 ↗
• MalfunctionMar 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  PER END USER HOSPITAL REPORT: "WITH ONE PORT PLACEMENT WE HAVE NOTED A SIGNIFICANT AMOUNT OF CROSS-TALK (FOR EXAMPLE: WE FIND THAT WHEN FLUSHING ONE SIDE OF A DUAL LUMEN PORT THERE IS BLOOD FLOW THAT MOVES TO OUTWARD THROUGH THE OTHER PORT LUMEN, WHICH WOULD BE UNUSUAL. THIS GIVES RISE TO A FEW POSSIBILITIES AS WE CAN SEE IT. 1) THERE IS PROBLEM WITH THE PORT INTEGRITY (A CRACK OR BREACH IN THE AREA BETWEEN THE CHAMBERS), CLOSE PROXIMITIES OF CATHETER LUMEN OR FLUID SHIFT BETWEEN THE CATHETERS FURTHER UP THE TUBE. THIS IS EVIDENCED BY WHAT WE SEE WITH BLOOD FLOW AS WELL AS THE PATIENT IS NOT RECEIVING EFFECTIVE EXCHANGE TRANSFUSIONS THROUGH APHERESIS. WE DO ALSO USE YOUR HIGH-FLOW NEEDLES (REF (B)(4)) FOR ACCESSING THE PORTS". ANGIODYNAMICS' ORIGINAL AWARE DATE WAS (B)(6) 2019, BUT IT WAS ORIGINALLY REPORTED THAT THE PORT WOULD BE LEFT IN PLACE. ON (B)(6) ANGIODYNAMICS WAS NOTIFIED THAT THE PORT WOULD BE REMOVED AND REPLACED ON (B)(6), AND THE COMPLAINT WAS RE-ASSESSED FOR REPORTABILITY. THE USED PORT HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Apheresis

  MAUDE report 8413622 ↗
• MalfunctionSep 6, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED ON A VORTEX PORT WHICH HAD BEEN PLACED IN SPRING 2016: "PATIENT WITH A DUAL LUMEN PORT BEING USED IN THE APHERESIS SETTING FOR RED BLOOD CELL EXCHANGE. "RECIRCULATION" NOTED ON USE WITH SUSPECTED "COMMUNICATION BETWEEN THE LUMENS". THE PORT HAS BEEN REPLACED AND WAS RETAINED FOR OUR INSPECTION. THE PROBLEM WAS FIRST NOTED ON (B)(6) 2018. THE PORT WAS NOT REMOVED UNTIL (B)(6) 2018 AND IT WAS REPLACED AT THE SAME TIME. DESCRIPTION OF EVENT IN PATIENT CHART ON (B)(6) 2018: PT. ARRIVED FOR HER OUTPATIENT RBC EXCHANGE, WITH HER MOTHER. PT. IS ALERT AND ORIENTED X3, VSS. PT'S PORT WAS ACCESSED, W/O DIFFICULTY, AND BOTH LUMENS WITHDREW BLOOD EASILY, AND BOTH LUMENS WERE INSTILLED WITH ALTEPLASE 2 MG. AFTER 30 MIN. THE ALTEPLASE WAS WITHDRAWN AND PORT WAS FLUSHED WITH NS. BOTH LUMENS OF PORT WITHDREW AND FLUSHED EASILY, WITH MINIMAL RESISTANCE. RBC EXCHANGE PROCEDURE WAS STARTED, AND THIS NURSE WAS LOOKING AT THE PORT SITE, TO SEE THAT THE INLET (DISTAL LUMEN) WAS WITHDRAWING BLOOD WELL, AND THE PROXIMAL LUMEN WAS CLEAR. THE INLET SIDE WAS DRAWING BLOOD INTERMITTENTLY WITH PINK TINGED SALINE. I EXAMINED THE TUBING IN THE MACHINE AND LOOKED BACK AT THE PORT SITE. AGAIN THE INLET

  Patient problems: Apheresis

  MAUDE report 7851904 ↗
• InjuryJun 25, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY HOSPITAL IN (B)(6), "DURING LINOGRAM SAW THAT CONTRAST WAS LEAKING OUT OF ONE PORT CHAMBER. THE DEVICE HAD BEEN IMPLANTED (B)(6) 2016." IT WAS REMOVED AND REPLACED ON (B)(6) 2018. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. THE USED DEVICE IS BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7634838 ↗
• InjuryMay 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED BY PHYSICIAN AT HOSPITAL IN (B)(6) UTILIZING VORTEX DUAL LUMEN PORT: "CONCERNING THE PROBLEMS ENCOUNTERED WITH VORTEX IN SICKLE CELL PATIENTS: WE HAVE MAINLY A LARGE PROBLEM OF JUGULAR THROMBOSES AND ESPECIALLY INTRA CARDIAC WITH A SIGNIFICANT INCIDENCE OF 7 THROMBOSES FOR 18 VORTEX POSED WITH 2 INTRACARDIAC THROMBOSES THAT HAVE BEEN COMPLICATED BY PULMONARY EMBOLISM. THESE THROMBOSES ARE MOST OFTEN ASYMPTOMATIC AND DETECTED BY TRANS-THORACIC ECHOCARDIOGRAPHY AND CONTROL ECHODOPPLER EVERY 6 MONTHS IN OUR UNIT. THEY OCCUR IN PATIENTS WITH AN INFLAMMATORY PROFILE AND FOR THE MAJORITY BEYOND ONE YEAR OF EXPOSURE." THE PORTS WERE BEING USED FOR APHERESIS WHICH IS NOT AN APPROVED APPLICATION FOR THIS DEVICE. ALL THROMBOSES WERE TREATED WITH XARELTO. THE PORT FOR THIS PATIENT REMAINS IN SITU.

  Patient problems: Thrombosis

  MAUDE report 7556235 ↗
• InjuryMay 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED BY PHYSICIAN AT HOSPITAL IN (B)(6) UTILIZING VORTEX DUAL LUMEN PORT: "CONCERNING THE PROBLEMS ENCOUNTERED WITH VORTEX IN SICKLE CELL PATIENTS: WE HAVE MAINLY A LARGE PROBLEM OF JUGULAR THROMBOSES AND ESPECIALLY INTRA CARDIAC WITH A SIGNIFICANT INCIDENCE OF 7 THROMBOSES FOR 18 VORTEX POSED WITH 2 INTRACARDIAC THROMBOSES THAT HAVE BEEN COMPLICATED BY PULMONARY EMBOLISM. THESE THROMBOSES ARE MOST OFTEN ASYMPTOMATIC AND DETECTED BY TRANS-THORACIC ECHOCARDIOGRAPHY AND CONTROL ECHODOPPLER EVERY 6 MONTHS IN OUR UNIT. THEY OCCUR IN PATIENTS WITH AN INFLAMMATORY PROFILE AND FOR THE MAJORITY BEYOND ONE YEAR OF EXPOSURE." THE PORTS WERE BEING USED FOR APHERESIS WHICH IS NOT AN APPROVED APPLICATION FOR THIS DEVICE. ALL THROMBOSES WERE TREATED WITH XARELTO. THE PORT FOR THIS PATIENT REMAINS IN SITU.

  Patient problems: Thrombosis

  MAUDE report 7556234 ↗
• InjuryMay 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED BY PHYSICIAN AT HOSPITAL IN (B)(6) UTILIZING VORTEX DUAL LUMEN PORT: "CONCERNING THE PROBLEMS ENCOUNTERED WITH VORTEX IN SICKLE CELL PATIENTS: WE HAVE MAINLY A LARGE PROBLEM OF JUGULAR THROMBOSES AND ESPECIALLY INTRA CARDIAC WITH A SIGNIFICANT INCIDENCE OF 7 THROMBOSES FOR 18 VORTEX POSED WITH 2 INTRACARDIAC THROMBOSES THAT HAVE BEEN COMPLICATED BY PULMONARY EMBOLISM. THESE THROMBOSES ARE MOST OFTEN ASYMPTOMATIC AND DETECTED BY TRANS-THORACIC ECHOCARDIOGRAPHY AND CONTROL ECHO DOPPLER EVERY 6 MONTHS IN OUR UNIT. THEY OCCUR IN PATIENTS WITH AN INFLAMMATORY PROFILE AND FOR THE MAJORITY BEYOND ONE YEAR OF EXPOSURE." THE PORTS WERE BEING USED FOR APHERESIS WHICH IS NOT AN APPROVED APPLICATION FOR THIS DEVICE. ALL THROMBOSES WERE TREATED WITH XARELTO. THE PORT FOR THIS PATIENT REMAINS IN SITU.

  Patient problems: Pulmonary Embolism

  MAUDE report 7556233 ↗
• InjuryMay 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED BY PHYSICIAN AT HOSPITAL IN (B)(6) UTILIZING VORTEX DUAL LUMEN PORT: "CONCERNING THE PROBLEMS ENCOUNTERED WITH VORTEX IN SICKLE CELL PATIENTS: WE HAVE MAINLY A LARGE PROBLEM OF JUGULAR THROMBOSES AND ESPECIALLY INTRA CARDIAC WITH A SIGNIFICANT INCIDENCE OF 7 THROMBOSES FOR 18 VORTEX POSED WITH 2 INTRACARDIAC THROMBOSES THAT HAVE BEEN COMPLICATED BY PULMONARY EMBOLISM. THESE THROMBOSES ARE MOST OFTEN ASYMPTOMATIC AND DETECTED BY TRANS-THORACIC ECHOCARDIOGRAPHY AND CONTROL ECHODOPPLER EVERY 6 MONTHS IN OUR UNIT. THEY OCCUR IN PATIENTS WITH AN INFLAMMATORY PROFILE AND FOR THE MAJORITY BEYOND ONE YEAR OF EXPOSURE." THE PORTS WERE BEING USED FOR APHERESIS WHICH IS NOT AN APPROVED APPLICATION FOR THIS DEVICE. ALL THROMBOSES WERE TREATED WITH XARELTO. THIS PORT HAS SINCE BEEN REMOVED.

  Patient problems: Thrombosis

  MAUDE report 7556232 ↗
• InjuryMay 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED BY PHYSICIAN AT HOSPITAL IN FRANCE UTILIZING VORTEX DUAL LUMEN PORT: "CONCERNING THE PROBLEMS ENCOUNTERED WITH VORTEX IN SICKLE CELL PATIENTS: WE HAVE MAINLY A LARGE PROBLEM OF JUGULAR THROMBOSES AND ESPECIALLY INTRA CARDIAC WITH A SIGNIFICANT INCIDENCE OF 7 THROMBOSES FOR 18 VORTEX POSED WITH 2 INTRACARDIAC THROMBOSES THAT HAVE BEEN COMPLICATED BY PULMONARY EMBOLISM. THESE THROMBOSES ARE MOST OFTEN ASYMPTOMATIC AND DETECTED BY TRANS-THORACIC ECHOCARDIOGRAPHY AND CONTROL ECHODOPPLER EVERY 6 MONTHS IN OUR UNIT. THEY OCCUR IN PATIENTS WITH AN INFLAMMATORY PROFILE AND FOR THE MAJORITY BEYOND ONE YEAR OF EXPOSURE." THE PORTS WERE BEING USED FOR APHERESIS WHICH IS NOT AN APPROVED APPLICATION FOR THIS DEVICE. ALL THROMBOSES WERE TREATED WITH XARELTO. THE PORT FOR THIS PATIENT REMAINS IN SITU.

  Patient problems: Thrombosis

  MAUDE report 7556231 ↗
• InjuryMay 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED BY PHYSICIAN AT HOSPITAL IN (B)(6) UTILIZING VORTEX DUAL LUMEN PORT: "CONCERNING THE PROBLEMS ENCOUNTERED WITH VORTEX IN SICKLE CELL PATIENTS: WE HAVE MAINLY A LARGE PROBLEM OF JUGULAR THROMBOSES AND ESPECIALLY INTRA CARDIAC WITH A SIGNIFICANT INCIDENCE OF 7 THROMBOSES FOR 18 VORTEX POSED WITH 2 INTRACARDIAC THROMBOSES THAT HAVE BEEN COMPLICATED BY PULMONARY EMBOLISM. THESE THROMBOSES ARE MOST OFTEN ASYMPTOMATIC AND DETECTED BY TRANS-THORACIC ECHOCARDIOGRAPHY AND CONTROL ECHODOPPLER EVERY 6 MONTHS IN OUR UNIT. THEY OCCUR IN PATIENTS WITH AN INFLAMMATORY PROFILE AND FOR THE MAJORITY BEYOND ONE YEAR OF EXPOSURE." THE PORTS WERE BEING USED FOR APHERESIS WHICH IS NOT AN APPROVED APPLICATION FOR THIS DEVICE. ALL THROMBOSES WERE TREATED WITH XARELTO. THE PORT FOR THIS PATIENT WAS REMOVED AND REPLACE BY ANOTHER VORTEX PORT.

  Patient problems: Pulmonary Embolism

  MAUDE report 7556230 ↗
• InjuryMay 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY HOSPITAL IN (B)(6): AN IMPLANTED VORTEX PORT WAS LEAKING "AT THE CONNECTION OF THE PORT AND THE CATHETER." THE PORT WAS REMOVED AND REPLACED WITH ANOTHER VORTEX PORT. THE REMOVED DEVICE WAS DISCARDED AT THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533504 ↗
• InjuryMay 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY HOSPITAL IN (B)(6): AN IMPLANTED VORTEX PORT WAS LEAKING AT / AROUND THE PORT SEPTEM ON THE RIGHT SIDE. THE PORT WAS REMOVED AND REPLACED WITH ANOTHER VORTEX PORT. THE REMOVED DEVICE WAS DISCARDED AT THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533496 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010767. One submission often covers many models, so check the product and lot details in each record.

• Z-0404-2011 · Sep 27, 2010 · Terminated
  Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816