Vortex MP-P5SDTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787MPP5SDT0), received between Jul 12, 2017 and Mar 25, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ANONYMOUS REPORTED SUBMITTED A USER FACILITY MEDWATCH, MW5166679, FOR A VORTEX MP 5FR SIL W/TRAY. A PATIENT WAS SCHEDULED FOR A REMOVAL AND REPLACEMENT PROCEDURE DUE TO THE IMPLANTED PORT NOT FUNCTIONING PROPERLY. UPON VISUALIZING THE PORT AT THE BEGINNING OF THE PROCEDURE, THE SURGEON DISCOVERED THAT THE CATHETER HAD BEEN BROKEN IN TWO PIECES. THE SURGICAL TEAM THEN PROCEEDED TO REMOVE THE CATHETER, FOLLOWING NORMAL PROCEDURES; HOWEVER, IT BEGAN TO SHATTER INTO DIFFERENT FRAGMENTS. THE SURGICAL TEAM WAS ABLE TO REMOVE ALL OF THE FRAGMENTS AND DID NOT IMPLANT A NEW PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687927 ↗
• MalfunctionJan 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2006, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' VORTEX PORT, PRODUCT CODE/REF: MP-P5SDT; LOT NO.:26330. THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD., AT (B)(6) HOSPITAL, IN (B)(6), WISCONSIN, FOR LONG-TERM VENOUS ACCESS FOR PLAINTIFF'S CHEMOTHERAPY. UPON INFORMATION AND BELIEF, THE AFOREMENTIONED DEVICE'S DESCRIPTION IS AS FOLLOWS: VORTEX MP LOW PROFILE TITANIUM PORT SYSTEM WITH ATTACHABLE 5F X76CM SILICONE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD., AT (B)(6)T HOSPITAL, IN (B)(6), WISCONSIN, FOR LONG-TERM VENOUS ACCESS FOR PLAINTIFF'S CHEMOTHERAPY. ON (B)(6)2010, THE REMOVAL OF THE PORT-A-CATH AT ISSUE WAS SCHEDULED WITH DR. (B)(6), MD. UPON REMOVAL OF SAID PORT-A-CATH, DR. (B)(6) NOTED THAT THE PORT AND COLLAR CAME AWAY EASILY WHILE THE CATHETER HAD FRACTURED AT THE DISTAL END OF THE LOCKING COLLAR. DURING THE AFOREMENTIONED REMOVAL PROCEDURE, THE CATHETER AT ISSUE FRACTURED YET AGAIN- AT THAT POINT, THE CATHETER FRACTURED INTO SEVERAL FRAGMENTS, ACCORDING TO DR. (B)(6). UPON INFORMATION AND BELIEF, THE AFOREMENTIONED REMOVAL PROCEDURE WAS TERMINATED UPON THE REMOVAL OF THE ENTIRE PORT AND CATHETER WITH THE EXCEPTION OF THE THREE FRAGMENTS OF TH

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 21146295 ↗
• InjuryFeb 7, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED: "PORT REMOVED FROM LEFT ANTERIOR CHEST. CATHETER WAS SECURED WITH HEMOSTAT AND CATHETER ADJACENT TO THE PORT BROKE WITH VERY LITTLE MANIPULATION. REMAINDER OF CATH WAS MOBILIZED AND SUBQ TISSUES SHOWED OBVIOUS SIGNS OF ABNORMAL TISSUE INGROWTH AND STRUCTURAL BREAKDOWN OF THE CATHETER WALL. THE PLACEMENT INCISION WAS OPENED. AND THE REMAINDER OF THE CATHETER IN THE SUBQ TRACT WAS REMOVED. AS SURGEON DELICATELY MOBILIZED THE CATHETER IN THE SOFT TISSUE TRAVELING UNDER THE CLAVICLE TOWARD THE INTRAVENOUS PORTION, THE CATHETER BROKE AND THE REMAINING INTRAVENOUS PORTION WAS UNABLE TO BE REMOVED. THE TRACT WAS SEWN OVER WITH 3-0 VICRYL FOR HEMOSTASIS AND THE INCISIONS WERE CLOSED IN 2 LAYERS. THE INTRAVENOUS PORTION OF THE CATHETER REMAINED IN PLACE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7248868 ↗
• InjuryJul 12, 2017Difficult to Remove; Difficult to Remove

  AS REPORTED TO ANGIODYNAMICS ON NOVEMBER 21, 2016: ON REMOVAL A PATIENT'S PORT, THE PORT TUBING VERY ROUGH AND ADHERED TO SUBCUTANEOUS TUNNEL WHEN PORT REMOVED. REMOVAL OF THE ENTIRE LENGTH OF TUBING REQUIRED A SECOND INCISION. THE PATIENT HAS BEEN DIAGNOSED WITH ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND WAS (B)(6) AT THE TIME OF THE EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Infiltration into Tissue

  MAUDE report 6708316 ↗

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-0132-2023 · Sep 20, 2022 · Open, Classified
  Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when
• 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