Simpulse 0057730Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741010422), received between Aug 6, 2020 and Nov 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Inability to Irrigate; Detachment of Device or Device Component; Inability to Irrigate; Detachment of Device or Device Component

  AS REPORTED, ON (B)(6) 2021, THE BARD/DAVOL SIMPULSE PLUS TIP DETACHED AND FAILED TO IRRIGATE WHILE ATTEMPTING TO PERFORM A WOUND WASHOUT PROCEDURE ON A PATIENT. IT WAS REPORTED THAT WATER COULD NOT BE DRAINED DUE TO DETACHED TIP OF THE DEVICE. THE AIR PRESSURE WAS APPROXIMATELY 50 PSI. AS REPORTED, THERE WAS NO DELAY IN COMPLETING THE PROCEDURE AND NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843864 ↗
• MalfunctionAug 6, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INSPECTION AT THE HOSPITAL WAREHOUSE, AN UNKNOWN PARTICULATE WAS OBSERVED INSIDE THE SOFT SPLASH SHIELD W/SHOWERHEAD TIP, SIMPULSE PLUS PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AS THE REPORTED PRODUCT ISSUE WAS DISCOVERED DURING INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10372466 ↗