SEISMIQ™ FG-010978Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850056723084), received between Jul 21, 2026 and Aug 6, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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.

• MalfunctionAug 6, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155523 ↗
• InjuryAug 6, 2026Communication or Transmission Problem

  It was reported that the console would not turn on and there was error message to restart the console. As a result, the procedure was not completed, requiring additional surgery.The SEISMIQ Intravascular Lithotripsy Console was selected for use. During the procedure, the console would not turn on and there was error message to restart the console. Troubleshooting was performed but the issue was not resolved. As a result, the procedure was not completed and additional surgery was required. No impact on the patient was reported. No further information was provided to Boston Scientific.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150481 ↗
• MalfunctionJul 21, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25898986 ↗