HydroPearlRecalls & reported problems across all models

We found 2 models of HydroPearl by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 injury.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HydroPearl recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 21, 2023Open, Classified

   Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

   Z-0868-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported HydroPearl problems

HydroPearl models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HydroPearl HP2S0600

  Agents, embolic, for treatment of uterine fibroids
  1 recall0 reports
• HydroPearl 8HP2S200

  Agents, embolic, for treatment of uterine fibroids
  1 report

Recent HydroPearl adverse event reports

The 1 most recent reports across all models, 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 ↗

Other Microvention, Inc. products

• Azur CX Detachable22 models · 509 reports · 1 recall
• Stent63 models · 237 reports · 2 recalls
• Azur Detachable Helical HydroCoil42 models · 190 reports
• V-Trak75 models · 147 reports
• WEB14 models · 134 reports
• AZUR14 models · 104 reports
• HydroSoft 3D26 models · 101 reports
• MicroPlex Helical Soft9 models · 8 reports · 1 recall