VortexRecalls & reported problems across all models

We found 14 models of Vortex by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2017 and May 5, 2026 — classified as 40 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Vortex recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 20, 2022Open, Classified

   Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

   Z-0132-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Vortex problems

Vortex models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vortex MP-P5SAT

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall7 reports
• Vortex LVTX5213

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  32 reports
• Vortex PSAX-10-I

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 reports
• Vortex MP-P5SDT

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 reports
• Vortex P5405K

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 reports
• Vortex P5305K

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• Vortex P5455K

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• Vortex SSAX-16-I

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• Vortex SSDX-16-I

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• Vortex P5355K

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Vortex MP-P5PT

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Vortex SPAX-16-I

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Vortex SPDX-16-I

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Vortex SSDX-10-I

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report

Recent Vortex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTVTX CATHETER PRODUCT, MODEL NUMBER MP-P5PT, LOT NUMBER 5073592. THE PORT CATHETER WAS IMPLANTED BY DR. (B)(6), AT (B)(6). IN OR ABOUT (B)(6) 2017, PLAINTIFF PRESENTED TO THE (B)(6), WITH CONCERNS RELATED TO HER PORT SITE. HER MEDICAL TEAM DETERMINED THAT SHE HAD DEVELOPED AN INFECTION AS WELL AS BLOOD CLOTS IN THE RIGHT INTERNAL JUGULAR. THE DEFECTIVE PORT WAS SUBSEQUENTLY REMOVED.

  Patient problems: Medical device site infection; Thrombosis/Thrombus

  MAUDE report 25089353 ↗
• 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 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER P5305K AND LOT NUMBER 5163667. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) FOR LACK OF VASCULAR ACCESS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF CHEST AND NECK PAIN. BLOOD CULTURES WERE DRAWN FROM THE PORT SITE. PLAINTIFF WAS SUBSEQUENTLY DISCHARGED WITH A PRESCRIPTION FOR ANTIBIOTICS PENDING RESULTS OF THE BLOOD CULTURE. ON OR ABOUT (B)(6) 2018, PLAINTIFF RETURNED TO (B)(6) HOSPITAL IN (B)(6), DUE TO CONTINUED DISCOMFORT AND THE POSITIVE BLOOD CULTURES THAT WERE PREVIOUSLY DRAWN. SHE WAS DISCHARGED HOME ON ANTIBIOTICS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), DUE TO ISSUES WITH THE ANTIBIOTICS SHE HAD BEEN PRESCRIBED. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT AN ULTRASOUND, WHICH DEMONSTRATED A THROMBOSIS IN HER LEFT INTERNAL JUGULAR VEIN. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE VORTEX NEEDED TO BE REMOVED DUE TO INFECTION AND THROMBOSIS. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE DEVICE. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (

  Patient problems: Bacterial Infection; Chest Pain; Neck Pain; Thrombosis/Thrombus

  MAUDE report 24480053 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2010, PLAINTIFF UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER P5405K, AND LOT NUMBER 508180. THE VORTEX WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6). THE PURPOSE OF IMPLANTATION OF THE VORTEX WAS TO ADMINISTER CHEMOTHERAPY TO TREAT PLAINTIFF'S LYMPHOMA. ON OR ABOUT (B)(6) 2014, PLAINTIFF PRESENTED TO (B)(6) WITH SYMPTOMS OF FACIAL AND UPPER NECK SWELLING, UPPER EXTREMITY SWELLING, AND RASH. PLAINTIFF SUBSEQUENTLY UNDERWENT A CT SCAN, WHICH REVEALED EVIDENCE OF THROMBUS SURROUNDING THE VORTEX PORT, REQUIRING REMOVAL OF THE DEVICE. ON OR ABOUT (B)(6) 2014, PLAINTIFF PRESENTED TO (B)(6) OUTPATIENT SURGERY IN (B)(6), TO UNDERGO REMOVAL OF DEFENDANTS' VORTEX DEVICE SECONDARY TO HER DEVELOPMENT OF THROMBOSIS AROUND THE PORT. THE REMOVAL PROCEDURE WAS PERFORMED BY (B)(6), M.D.

  Patient problems: Rash; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24465481 ↗
• MalfunctionFeb 26, 2026Fracture; Detachment of Device or Device Component; Infusion or Flow Problem

  ON OR ABOUT (B)(6) 2007, PLAINTIFF UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER SSAX-16-1, AND LOT NUMBER 27839. THE VORTEX WAS IMPLANTED BY DR. (B)(6), AT (B)(6) HOSPITAL (B)(6). ON OR ABOUT (B)(6) 2007, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL (B)(6) FOR REMOVAL OF THE VORTEX GIVEN THE DEVICE WAS NO LONGER NEEDED AND WAS NOT FLUSHING PROPERLY. ON OR ABOUT (B)(6) 2007, DR. (B)(6) ATTEMPTED TO REMOVE THE VORTEX DEVICE, AND WHILE HE WAS ABLE TO REMOVE THE PORT BODY ITSELF, HE DISCOVERED THAT THE CATHETER PORTION OF THE DEVICE HAD FRACTURED AND MIGRATED. PLAINTIFF UNDERWENT IMAGING, WHICH CONFIRMED A FRAGMENT OF THE FRACTURED CATHETER REMAINED IN HIS BODY. ON OR ABOUT (B)(6) 2007, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6) TO UNDERGO RETRIEVAL OF THE FRACTURED CATHETER FRAGMENT. THE RETRIEVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), AND SHE WAS ABLE TO SUCCESSFULLY RETRIEVE THE ENTIRE CATHETER FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465480 ↗
• 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 ↗
• MalfunctionFeb 9, 2026Fracture

  ON OR ABOUT (B)(6) 2008, PLAINTIFF UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX PORT CATHETER PRODUCT, WITH MODEL NUMBER P5455K, AND LOT NUMBER 31732. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), ALABAMA FOR LONG-TERM ANTIBIOTIC THERAPY. ON OR ABOUT (B)(6) 2013, PLAINTIFF PRESENTED TO (B)(6), ALABAMA TO UNDERGO A CHEST X-RAY TO EVALUATE PLAINTIFF'S DYSPNEA (SHORTNESS OF BREATH), AND THE X-RAY REVEALED CATHETER FRACTURE. ON OR ABOUT (B)(6) 2013, PLAINTIFF PRESENTED TO (B)(6), ALABAMA TO UNDERGO RETRIEVAL OF A CATHETER FRAGMENT LOCATED IN PLAINTIFF'S RIGHT ATRIUM. THE FRAGMENT RETRIEVAL OPERATION WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT (B)(6) 2013, PLAINTIFF PRESENTED TO (B)(6), ALABAMA TO UNDERGO REMOVAL OF THE REMAINING VORTEX PORT CATHETER DEVICE. THE PROCEDURE WAS PERFORMED BY DR. (B)(6)..

  Patient problems: Dyspnea

  MAUDE report 24293997 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) WAS BORN ON (B)(6) 2006. AT NEARLY TWO (2) YEARS OLD, ON (B)(6) 2008, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' VORTEX MP DEVICE, CATALOG # MP-P5SAT, LOT # 956882. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: VORTEX MP LOW PROFILE TITANIUM PORT SYSTEM WITH ATTACHED 5F X 76CM SILICONE CATHETER. THE DEVICE AT ISSUE WAS IMPLANTED BY DR.(B)(6) , M.D., (B)(6) FOR THE CHEMOTHERAPY TREATMENT OF PLAINTIFF'S ASTROCYTOMA OF THE SPINAL CORD. ON OR AROUND (B)(6) 2011, PLAINTIFF PRESENTED TO (B)(6). (B)(6) WITH HIS MOTHER FOR THE SCHEDULED REMOVAL OF PLAINTIFF'S VORTEX MP. UPON INFORMATION AND BELIEF, (B)(6) PORT WAS REMOVED WITH THE USE OF A BOVIE ELECTROCAUTERY BY DR.(B)(6) , MD, AT(B)(6) . ON OR AROUND (B)(6) 2012 PLAINTIFF PRESENTED BACK TO (B)(6) HOSPITAL AT (B)(6) WITH HIS MOTHER FOR SCHEDULED PHYSICAL THERAPY WHERE PLAINTIFF'S MEDICAL TEAM ORDERED AN MRI OF HIS SPINE. IT WAS FOUND IN THE IMAGING THAT A PORTION OF THE PORT APPEARED TO BE RETAINED IN THE ANTERIOR CHEST WALL SOFT TISSUES. IT WAS CONFIRMED THROUGH IMAGING ON (B)(6) 2012 THAT THE RETAINED CONNECTOR WAS IN THE RIGHT UPPER CHEST WALL SOFT TISSUES. AFTER REMOVAL OF THE DEFECTIVE VORTEX MP POR

  Patient problems: Foreign Body In Patient

  MAUDE report 23829939 ↗
• MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER PRODUCT, WITH MODEL NUMBER H787P5355KO, AND LOT NUMBER H787P5355K0. THE VORTEX DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED (B)(6) MEDICAL CENTER, (B)(6) FOR PORT REMOVAL DUE TO PORT MALFUNCTION. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6). DURING THE PROCEDURE, DR. (B)(6) OBSERVED THAT THE DISTAL PORTION OF THE CATHETER HAD EMBOLIZED INTO THE RIGHT ATRIUM AND WAS UNABLE TO RETRIEVE THE FRAGMENT. ON OR ABOUT (B)(6) 2024, PLAINTIFF SUCCESSFULLY UNDERWENT FRAGMENT RETRIEVAL VIA THE GROIN. THE PROCEDURE WAS PERFORMED BY DR.(B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727128 ↗
• 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 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS RECEIVED A MEDSUN REPORT THAT REPORTED AN ISSUE WITH A VORTEX MP 5FR SIL W/TRAY. THE FOLLOWING WAS REPORTED: "A PATIENT PRESENTED FOR A MEDIPORT REMOVAL PROCEDURE DUE TO COMPLETION OF CHEMOTHERAPY TREATMENT. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND AFTER INDUCTION OF GENERAL ANESTHESIA, PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION USING CHLORAPREP WITH THE HEAD TURNED TO THE LEFT. LOCAL ANESTHETIC WAS INJECTED AROUND THE PREVIOUS SCAR. AN INCISION WAS MADE THROUGH THE PREVIOUS SCAR. DISSECTION WAS CARRIED DOWN TO THE PORT AND THERE WAS A CAPSULE AROUND THE PORT SITE THAT WAS OPENED AND REMOVED FROM THE PORT. THE PORT AND THE CONNECTED CATHETER WERE EXTRICATED AND DISSECTED AS DISTAL AS POSSIBLE. THERE WAS STILL SIGNIFICANT TENSION ON THE CATHETER. THE CATHETER WAS ALSO NOTED TO BE BRITTLE. TO FURTHER DISSECT OUT THE CATHETER, A COUNTER-INCISION WAS MADE AT THE CERVICAL SCAR WHERE THE CATHETER COULD BE PALPATED. DISSECTION WAS CARRIED DOWN TO THE RIGHT INTERNAL JUGULAR VEIN AND SELF-RETAINING RETRACTORS PLACED. THE CATHETER FRACTURED PROXIMAL TO A HEMOSTAT. FURTHER BLUNT DISSECTION WAS CAREFULLY CARRIED DOWN AND CALCIFICATIONS WERE PEELED OFF TH

  Patient problems: Foreign Body In Patient

  MAUDE report 23284788 ↗
• MalfunctionSep 18, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX TITANIUM PORT SYSTEM, WITH MODEL NUMBER P54565K, AND LOT NUMBER 5218796. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6), FOR CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6), FOR PREOPERATIVE WORKUP AND TESTING PRIOR TO UNDERGOING A COLONOSCOPY, WHICH INCLUDED A CHEST X-RAY, THAT REVEALED THE CATHETER PORTION OF THE VORTEX HAD FRACTURED AND MIGRATED. BASED ON THE X-RAY FINDINGS, ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6), TO UNDERGO REMOVAL OF THE VORTEX PORT AND THE FRACTURED CATHETER. THIS REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Failure of Implant

  MAUDE report 23088582 ↗
• MalfunctionJul 23, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2010, MINOR PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PRODUCT, MODEL NUMBER: MP-P5SAT AND LOT NUMBER: 513785. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6) MEDICAL CENTER IN (B)(6) TEXAS, FOR THE PURPOSE OF TREATING HYPOGAMMAGLOBULINEMIA. ON OR ABOUT (B)(6) 2015, MINOR PLAINTIFF UNDERWENT REMOVAL OF THE PORT BY DR. (B)(6) M.D., AT (B)(6) MEDICAL CENTER. DURING THE PROCEDURE, DR. MILLER DISCOVERED THAT THE INDWELLING CATHETER FRACTURED IN TWO LOCATIONS. ON OR ABOUT (B)(6) 2015, MINOR PLAINTIFF UNDERWENT AN ADDITIONAL PROCEDURE IN AN ATTEMPT TO REMOVE THE FRACTURED CATHETER. THE PROCEDURE, PERFORMED BY DR. (B)(6) M.D., WAS UNSUCCESSFUL. A FRAGMENT OF THE CATHETER REMAINS INSIDE OF MINOR PLAINTIFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 22579217 ↗

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