Vortex PSAX-10-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787PSAX10I0), received between Sep 12, 2017 and Apr 17, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K032557); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER EXPERIENCED AN ISSUE WITH A PH LOW PROFILE VORTEX PORT. ON (B)(6) 2023, IT WAS REPORTED THAT A VORTEX PORT WAS RECENTLY BEEN REMOVED, AT WHICH TIME, IT WAS NOTED ON THE ULTRASOUND THAT THERE WAS STILL SOMETHING "LEFT BEHIND" UNDER THE CLAVICLE. IT WAS CONCLUDED THAT THE ITEM RETAINED WAS LIKELY THE "WHITE BOOT" (SLEEVE, STRAIN RELIEF) THAT WAS LEFT IN-SITU AFTER EXPLANTATION. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16755021 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT'S PH LOW PROFILE VORTEX PORT WAS INSERTED ON (B)(6) /2022. THE PORT WAS ACCESSED THREE TIMES AFTER INSERTION- ONCE FOR PET/GA, ONCE POSTOPERATIVELY AND ONCE FOR LINEOGRAM. WHILE ASSESSING THE PORT FOR GA, PRIOR TO PET SCAN, THE CLINICIAN WAS UNABLE TO ASPIRATE OR FLUSH THE LINE. SUBSEQUENTLY, THERE WAS SWELLING OVER THE MIDPOINT OF THE LINE. THERE WAS A NORMAL LINEOGRAM, WITH NO LEAK, BUT PERSISTENT SWELLING 5 MINUTES AFTER ANY INFUSION WAS COMMENCED, ALONG WITH PAIN. ULTIMATELY, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME DEVICE. THE SURGEON PRESUMES THIS WAS CAUSED BY A PIN HOLE, ALONG THE IMPLANTED LINE, AS IT IS WELL AWAY FROM ANY SURGICAL WOUND WHERE THERE COULD HAVE BEEN INADVERTENT PUNCTURE OF THE LINE WHILST SUTURING. THERE IS NO CLEAR EVIDENCE OF LEAK ON LINEOGRAM BUT THE LINE FLUSHES WELL AND IT TAKES 5 MINUTES OF INFUSION FOR THE LEAK TO BECOME APPARENT. THE PATIENT WAS REPORTED AS STABLE AND HAS NOT SUFFERED FROM ANY COMPLICATIONS FOLLOWING REPLACEMENT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315061 ↗
• InjuryApr 26, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DIFFICULTY WAS ENCOUNTERED ON (B)(6) 2017 BY A PHYSICIAN ATTEMPTING TO REMOVE A SMART PORT WHICH HAD BEEN INSERTED IN 2014 (EXACT DATE UNKNOWN) : "TUBING VERY ROUGHENED; TOOK UNUSUAL FORCE TO REMOVE, VERY NEARLY NEEDED EXTRA INCISION." NO INJURY TO PATIENT WAS REPORTED. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7465269 ↗
• InjuryFeb 21, 2018Crack; Crack

  AS REPORTED, VORTEX PORT HAD BEEN IMPLANTED SINCE (B)(6) 2008. UPON EXPLANT IN (B)(6) 2018 THE CATHETER FRACTURED AND HAD TO BE RETRIEVED AND REMOVED (SNARED) BY AN INTERVENTIONAL CARDIOLOGIST. THE USED DEVICE WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7286507 ↗
• InjuryFeb 15, 2018Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED, "ON ATTACHED PORT, THE CONNECTOR CAME OFF AND HAD TO BE SURGICALLY REMOVED. ALSO THE PATIENT HAD A CATH LAB PROCEDURE. THE PHYSICIAN SAID THE CATHETER HAD EMBOLIZED."

  Patient problems: Embolism; Patient Problem/Medical Problem

  MAUDE report 7274487 ↗
• InjurySep 12, 2017Fracture; Fracture

  AS REPORTED, CATHETER SPLIT/BROKE IN PATIENT AND WAS REMOVED ON (B)(6) 2017. PORT HAD BEEN PLACED ON (B)(6) 2017 BY DR. (B)(6). THE INITIAL X-RAY AFTER THE PORT PLACEMENT SHOWED THE CATHETER IN ONE PIECE. NO SAMPLE WILL BE RETURNED, HOWEVER X-RAYS OF THE DEVICE PRIOR TO REMOVAL WERE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858985 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032557. One submission often covers many models, so check the product and lot details in each record.

• Z-0403-2011 · Sep 27, 2010 · Terminated
  Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816