SIMPULSE 0067570Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741010125), received between May 11, 2017 and Oct 17, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Break; Break

  AS REPORTED, DURING PREPARATION FOR AN ORTHO RECON PROCEDURE ON (B)(6) 2022, IT WAS NOTED WHEN BARD/DAVOL SIMPULSE SOLO DEVICE REMOVED FROM PACKAGING THE BATTERY HOLDER CLIP WAS BROKEN OFF AT ONE END. IT WAS ALSO REPORTED THAT THE DEVICE WAS SWITCHED OUT BEFORE THE CASE BEGUN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615081 ↗
• MalfunctionNov 12, 2021Inability to Irrigate; Detachment of Device or Device Component; Inability to Irrigate; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL SIMPULSE SOLO DEVICE WAS USED. THE DEVICE FAILED TO DRAIN WATER SUDDENLY. IT WAS REPORTED THAT THE SALINE WAS NOT DISCHARGED FROM THE DEVICE (THE DEVICE FAILED TO IRRIGATE) DURING TEST. THERE WAS NO REPORTED PATIENT INJURY. SAMPLE RETURN EVALUATION FOUND THE BATTERY LATCH HAD DETACHED FROM THE BATTERY CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806837 ↗
• MalfunctionJan 16, 2020Break; Break

  IT WAS REPORTED THAT THE LATCH OF THE BATTERY CAP COMPARTMENT IS BROKEN OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THE DEVICE NOT USED ON PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9595759 ↗
• MalfunctionJan 16, 2020Break; Break

  IT WAS REPORTED THAT THE LATCH OF THE BATTERY CAP COMPARTMENT IS BROKEN OFF OF THE SIMPULSE SOLO SUCTION IRRIGATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9595640 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT THE LOWER PART OF THE SIMPULSE SOLO HANDLE WAS DAMAGED AFTER OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9480343 ↗
• MalfunctionAug 17, 2017Break; Break

  DURING THE SAMPLE EVALUATION OF A SIMPULSE SOLO IRRIGATOR REPORTED AS NOT FUNCTIONING, THE LATCH ON THE BATTERY CASE WAS FOUND BROKEN OFF. THE LATCH WAS RETURNED WITH THE SAMPLE.

  Patient problems: No Patient Involvement

  MAUDE report 6801766 ↗
• MalfunctionMay 11, 2017Break; Inability to Irrigate; Break; Inability to Irrigate

  INFORMATION AS REPORTED BY THE USER FACILITY: DURING THE SAMPLE EVALUATION OF A SIMPULSE SOLO IRRIGATOR REPORTED AS NOT IRRIGATING, THE LATCH ON THE BATTERY CASE WAS FOUND BROKEN OFF AND NOT RETURNED. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP INDICATED THE USER FACILITY RELEASED THE LATCH TO REMOVE THE BATTERIES AND THE LATCH ON THE BOTTOM OF THE HAND PIECE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6561803 ↗