VersaPulse PowerSuite 80WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290109140599), received between Sep 20, 2022 and Nov 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A WEAK OUTPUT OBSERVED, THERE WAS NOT ANY ERROR DISPLAYED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685296 ↗
• MalfunctionOct 4, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN INSPECTION OF THE DEVICE UPON ITS RETURN, THE EMERGENCY BUTTON WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370540 ↗
• MalfunctionJan 2, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT, THE CONSOLE SCREEN WAS BLANK, AND NOTHING WAS DISPLAYED WHEN TRIED TO USE THE DEVICE. IT WAS REBOOTED SEVERAL TIMES WITH NO IMPROVEMENT, SO THE CASE WAS DISCONTINUED. THE PATIENT WAS STABLE UNDER GENERAL ANESTHESIA. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426080 ↗
• MalfunctionMar 3, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE VERSAPULSE DID NOT START DURING A PROCEDURE. THE ERROR 221 WAS SHOWED IN THE SCREEN. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479782 ↗
• MalfunctionSep 20, 2022Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CONSOLE BECAME UNSTABLE. AFTER REBOOTING, THE SCREEN TURNED RED. THE PROCEDURE WAS CANCELLED AND NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT SEDATION STATUS OF UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457583 ↗