Vortex SSDX-16-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787SSDX16I0), received between Aug 29, 2023 and Oct 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K951814); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2018, A VORTEX PORT CATHETER, LOT #5131154 WAS IMPLANTED IN PLAINTIFF'S LEFT SIDE CHEST. THE PROCEDURE WAS PERFORMED BY DR. (B)(6) AT (B)(6). PLAINTIFF'S PORT CATHETER WAS REMOVED ON OR ABOUT (B)(6) 2023, BY DR. (B)(6), AT (B)(6) HOSPITAL, AS IT WAS NO LONGER NEEDED. AT THE TIME OF THE SURGICAL REMOVAL ON (B)(6) 2023, DR. (B)(6) HAD DIFFICULTY REMOVING THE VORTEX PORT. DURING THE REMOVAL, A PORTION OF THE VORTEX CATHETER BROKE AND REMAINED IN PLAINTIFF'S BODY, UNBEKNOWNST TO DR. (B)(6) OR PLAINTIFF. FOR SEVERAL WEEKS/MONTHS THEREAFTER, PLAINTIFF EXPERIENCED LEFT SIDE CHEST PAIN, PLEURITIC, AND PALPATIONS WHICH WOULD WORSEN WHEN PLAINTIFF LAID ON HIS LEFT SIDE. PLAINTIFF WAS TREATED FOR CHEST PAIN, PALPITATIONS AND SHORTNESS OF BREATH ON (B)(6) 2023 AT THE (B)(6) HOSPITAL. IN THE COURSE OF HIS TREATMENT IN (B)(6) 2023, A CT WAS PERFORMED WHICH SHOWED "CALCIFIED RIGHT ATRIAL MASS SEEN ON ECHO SHOWING UP ON CT AS RETAINED FRAGMENT IN LEFT BRACHIOCEPHALIC VEIN". DUE TO THE LOCATION OF THE RETAINED FRAGMENT AND THE RISK TO PLAINTIFF FOR AN ATTEMPTED REMOVAL OF THE FRAGMENT, THE DECISION WAS MADE TO LEAVE THE RETAINED VORTEX FRAGMENT IN PLAINTIFF'S BODY. TO DATE, THE RETAINED F

  Patient problems: Arrhythmia; Chest Pain; Foreign Body In Patient; Unspecified Heart Problem

  MAUDE report 20516097 ↗
• MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2018, A VORTEX PORT CATHETER, LOT #5131154 WAS IMPLANTED IN PLAINTIFF'S LEFT SIDE CHEST. THE PROCEDURE WAS PERFORMED BY DR. (B)(6) AT (B)(6) CENTER. PLAINTIFF'S PORT CATHETER WAS REMOVED ON OR ABOUT (B)(6) 2023, BY DR. (B)(6), AT (B)(6) HOSPITAL OF THE, AS IT WAS NO LONGER NEEDED. AT THE TIME OF THE SURGICAL REMOVAL ON (B)(6) 2023, DR. (B)(6) HAD DIFFICULTY REMOVING THE VORTEX PORT. DURING THE REMOVAL, A PORTION OF THE VORTEX CATHETER BROKE AND REMAINED IN PLAINTIFF'S BODY, UNBEKNOWNST TO DR. (B)(6) OR PLAINTIFF. FOR SEVERAL WEEKS/MONTHS THEREAFTER, PLAINTIFF EXPERIENCED LEFT SIDE CHEST PAIN, PLEURITIC, AND PALPATIONS WHICH WOULD WORSEN WHEN PLAINTIFF LAID ON HIS LEFT SIDE. PLAINTIFF WAS TREATED FOR CHEST PAIN, PALPITATIONS AND SHORTNESS OF BREATH ON (B)(6) 2023 AT THE HOSPITAL OF (B)(6). IN THE COURSE OF HIS TREATMENT IN (B)(6) 2023, A CT WAS PERFORMED WHICH SHOWED "CALCIFIED RIGHT ATRIAL MASS SEEN ON ECHO SHOWING UP ON CT AS RETAINED FRAGMENT IN LEFT BRACHIOCEPHALIC VEIN". DUE TO THE LOCATION OF THE RETAINED FRAGMENT AND THE RISK TO PLAINTIFF FOR AN ATTEMPTED REMOVAL OF THE FRAGMENT, THE DECISION WAS MADE TO LEAVE THE RETAINED VORTEX FRAGMENT IN PLAINTIFF'S BODY. TO DAT

  Patient problems: Arrhythmia; Chest Pain; Foreign Body In Patient; Unspecified Heart Problem

  MAUDE report 20509246 ↗
• InjuryAug 29, 2023Material Separation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Separation; Detachment of Device or Device Component; Device Dislodged or Dislocated

  (B)(4), A LEGAL GROUP, NOTIFIED ANGIODYNAMICS OF AN INCIDENT REGARDING A TRIUMPH VORTEX PORT. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF THE TRIUMPH VORTEX PORT, DET W/10F INTRO DEVICE. THE DEVICE WAS IMPLANTED BY DR. (B)(6) , M.D., AT (B)(6) , FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED HIMSELF TO (B)(6) FOR PORT REMOVAL. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT PLAINTIFF'S PORT WAS MALFUNCTIONING AND CAUSING EXTREME PAIN TO PLAINTIFF. DURING REMOVAL OF THE VORTEX PORT ON (B)(6) 2019, PLAINTIFF'S MEDICAL TEAM NOTICED THAT THE CATHETER SEGMENT APPEARED TOO SHORT. AN X-RAY WAS TAKEN, AND IT REVEALED THAT PART OF THE CATHETER BROKE OFF AND HAD TRAVELED TO PLAINTIFF'S HEART. PLAINTIFF UNDERWENT A SECOND SURGERY ON AN EMERGENCY BASIS TO REMOVE THE FOREIGN FRAGMENT FROM HIS HEART ON (B)(6) 2019. AS A RESULT OF HAVING THE VORTEX IMPLANTED, PLAINTIFF HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE CORRECTIVE SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVI

  Patient problems: Emotional Changes; Foreign Body In Patient; Implant Pain

  MAUDE report 17643858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951814. One submission often covers many models, so check the product and lot details in each record.

• Z-0406-2011 · Sep 27, 2010 · Terminated
  Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.