HydroPearl 8HP2S200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812636020624), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K150870); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CHEMOEMBOLIZATION TREATMENT WAS PERFORMED ON A VESSEL IN THE LIVER. PRIOR TO DELIVERY OF THE LIFEPEARL DEVICE, ANGIOGRAMS WITH CONTRAST MEDIA WERE TAKEN WITHOUT ANY PROBLEMS. AFTER REACHING THE TARGET VESSEL, THE LIFEPEARL LOADED WITH 50 MG DOXORUBICIN WAS MIXED WITH 8 ML NACL AND 8 ML CONTRAST MEDIA. IMMEDIATELY AFTER BEGINNING THE SLOW INJECTION, THE PATIENT FELT WARM AND HAD A "WARM HEAD." A COOL COMPRESS WAS PUT ON THE PATIENT'S HEAD AND A SMALL AMOUNT OF THE LIFEPEARL WAS INJECTED. THE PATIENT BEGAN TO MOVE AND "GET NERVOUS." HYDROPEARL WAS THEN INJECTED TO ENSURE THE EMBOLIZATION WAS COMPLETED. AT THIS TIME, THE PATIENT'S BLOOD PRESSURE AND RESPIRATION RATE DROPPED RAPIDLY AND HE BECAME UNCONSCIOUS. SOLU DECORTIN AND IV ADRENALIN WERE ADMINISTERED TO STABILIZE THE PATIENT. AFTER PREPARATION FOR INTUBATION AND CARDIAC RESUSCITATION, THE PATIENT SLOWLY BEGAN TO RECOVER. NO RESUSCITATION WAS REQUIRED. THERE WAS NO REPORTED ISSUE WITH THE PREPARATION OR DELIVERY OF THE HYDROPEARL.

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 9742509 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150870. One submission often covers many models, so check the product and lot details in each record.

• Z-0868-2024 · Dec 21, 2023 · Open, Classified
  TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600