Vortex MP-P5SATRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H787MPP5SAT0), received between Nov 7, 2017 and Dec 17, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K033473); 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.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT WAS SCHEDULED FOR REMOVAL OF THIER BROVIAC CATHETER IMPLANT DUE TO CLOTTING OFF AND END OF USE. DURING THE REMOVAL, THE CATHETER BROKE OFF IN PIECES. IT WAS CONFIRMED THE FRAGMENT WAS LODGED IN THE VESSEL. THE DOCTORS ASSISTED IN REMOVAL, HOWEVER WERE UNABLE TO REACH THE FRAGMENT. IR WAS CONSULTED, AND THE IR DOCTOR REQUESTED THE PATIENT TO BE TRANSPORTED TO IR TO RETRIEVE THE RETAINED CATHETER FRAGMENT. THE PORT AND CATHETER WERE REMOVED AND THE CATHETER FRAGMENT WAS SENT TO PATHOLOGY FOR EXAMINATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18106223 ↗
• MalfunctionJul 17, 2023Fracture; Fracture

  THE PROVIDER REPORTED THEY HAD TO REMOVE THE PATIENT'S VORTEX MP 5FR PORT THAT HAD BEEN PLACED ON (B)(6) 2023. AFTER A FEW TRANSFUSIONS, THE PATIENT HAD STARTED TO EXPERIENCE PAIN SO THAT IS WHY THEY DECIDED TO REMOVE AND REPLACED IT. WHEN EXPLANTED, THE CATHETER HAD 2 FRACTURES IN IT , NEAR THE HUB AND ANOTHER ONE TOWARDS THE DISTAL END. THEY KNOW THERE WERE A COUPLE OF TREATMENTS ADMINISTERED THROUGH THE PORT IN THAT TIME FRAME, BUT THEY DID NOT HAVE THE EXACT AMOUNT. DURING THE LAST TREATMENT ADMINISTERED, THE PATIENT COMPLAINED OF PAIN. UPON FURTHER INVESTIGATION, THAT'S HOW THEY DISCOVERED THE CATHETER WAS FRACTURED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17334715 ↗
• MalfunctionApr 1, 2022Fracture; Fracture

  ANGIODYNAMICS RECEIVED FDA REPORT REFERENCE: (B)(4). A NURSE REPORTED AN ISSUE WITH A VORTEX PORT (VORTEX MP 5FR SIL W/TRAY PG). THE PATIENT'S TREATMENT WAS COMPLETED, SO THE PORT AND CATHETER WERE BEING REMOVED. THE PORT WAS ACCESSED FOR CHEMOTHERAPY AFTER PLACEMENT ONCE WEEKLY FOR 1-2 MONTHS, AND EVERY THREE WEEKS AFTER THAT. DURING THE REMOVAL PROCEDURE, WHEN THE SURGEON WENT TO REMOVE THE PORT SYSTEM, THE SILICONE CATHETER PORTION BROKE APART. THE FOLLOWING IS THE SURGEON'S OPERATIVE NOTE: "THE THREE ANCHORING PROLENE SUTURES WERE DIVIDED AND REMOVED. THE PORT WAS TAKEN OUT OF ITS SUBCUTANEOUS POCKET. THE CATHETER HAD ROUGH SURFACE. WITH TRACTION, THE CATHETER CAME OUT OF THE TUNNEL, BUT IT FRACTURED IN THE SUBCLAVICULAR AREA AND ONLY THE PORTION FROM THE TUNNEL CAME OUT. WE HAD A RETAINED INTRAVASCULAR CATHETER FRAGMENT. THERE WAS NO BLEEDING FROM THE SITE. C-ARM WAS USED, AND THE CATHETER WAS FOUND TO BE FRACTURED AT THE MIC-CLAVICLE LEVEL; TOO DEEP TO EXPLORE FROM A SUBCLAVIAN APPROACH. SEEMED TO BE IN A STABLE POSITION." THE SURGICAL WOUND WAS CLOSED. THE SURGEON THEN DISCUSSED THE CASE WITH AN INTERVENTIONAL RADIOLOGIST (IR). THE IR PERFORMED ENDOVASCULAR RETRIEVAL OF THE

  Patient problems: Foreign Body In Patient

  MAUDE report 13977652 ↗
• InjuryNov 7, 2017Crack; Crack

  AS REPORTED VIA VOLUNTARY USER MEDWATCH # (B)(4): "PREOPERATIVE DIAGNOSIS: PORT-A-CATH MALFUNCTION W/SEPARATION OF CATHETER FROM PORT; PHYSICIAN REMOVED PORT AND CATHETER THAT WAS BROKEN AT THE POINT THE CATHETER AND PORT ATTACH. PHYSICAN/SURGEON WANT THE PORT TO BE EXAMINED TO FIND OUT IF IT WAS DEFECTIVE. PORT IS APPROXIMATELY 3 YEARS OLD AND WAS PLACED AT ANOTHER HOSPITAL 3 YEARS AGO. POSTOPERATIVE DIAGNOSIS: PORT-A-CATH MALFUNCTION WITH SEPARATION OF CATHETER FROM PORT; PORT HAD BEEN SUCCESSFUL UNTIL 2 DAYS AGO WHEN IT COULD NOT BE USED BY THE HOME HEALTH NURSE. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM; A PERIPHERAL IV WAS STARTED AND HE WAS GIVEN HIS IMMUNOGLOBULIN WITHOUT DIFFICULTY. SUBSEQUENTLY, HE PRESENTED TO SURGEONS CLINIC WHERE REVIEW OF X-RAY DEMONSTRATED THAT THE CATHETER WAS ACTUALLY NO LONGER ATTACHED TO THE PORT, EXPLAINING THE MALFUNCTION." PORT ORIGINALLY PLACED (B)(6) 2014. WAS REMOVED ON (B)(6) 2017. PORT HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005880 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033473. One submission often covers many models, so check the product and lot details in each record.

• Z-3071-2011 · Aug 30, 2010 · Terminated
  Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816 Indicated for central venous placement (ei