SIMPULSE 0067590Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741010132), received between Mar 26, 2018 and Apr 11, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 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.

• MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ABDOMINAL WASHOUT PROCEDURE ON (B)(6) 2024, THE TIP OF THE SIMPULSE SOLO POPPED OFF INTO THE PATIENT'S ABDOMEN. IT WAS REPORTED THAT THE TIP WAS RETRIEVED AND ANOTHER SIMPULSE SOLO WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086358 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL SIMPULSE SOLO LEAKED IRRIGATION FLUID AT THE TRIGGER END OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531837 ↗
• MalfunctionAug 12, 2021Inability to Irrigate; Detachment of Device or Device Component; Inability to Irrigate; Detachment of Device or Device Component

  AS REPORTED, DURING ORTHOPEDICS PROCEDURE ON (B)(6) 2021 A SIMPULSE SOLO W/SOFT SPLASH SHIELD TIP DEVICE WAS USED. THE DEVICE STOPPED WORKING HALF WAY THROUGH THE PROCEDURE AND A NEW ONE WAS OPENED. IT WAS REPORTED THAT THREE SIMPULSE SOLO DEVICES WERE OPENED AND USED DURING THE SAME PROCEDURE AND ALL THE DEVICES STOPPED WORKING HALF WAY THROUGH THE PROCEDURE. AS REPORTED, THE PROCEDURE WAS COMPLETED USING ANOTHER SIMPULSE SOLO DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315741 ↗
• MalfunctionAug 12, 2021Inability to Irrigate; Detachment of Device or Device Component; Inability to Irrigate; Detachment of Device or Device Component

  AS REPORTED, DURING ORTHOPEDICS PROCEDURE ON (B)(6) 2021 A BARD/DAVOL SIMPULSE SOLO W/SOFT SPLASH SHIELD TIP DEVICE WAS USED. THE DEVICE STOPPED WORKING HALF WAY DURING PROCEDURE AND NEW ONE WAS OPENED. IT WAS REPORTED THAT THREE BARD/DAVOL SIMPULSE WERE OPENED AND USED ON THE SAME PROCEDURE AND ALL THE DEVICES STOPPED WORKING HALF WAY DURING PROCEDURE. AS REPORTED, THE PROCEDURE WAS COMPLETED USING ANOTHER BARD/DAVOL SIMPULSE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315740 ↗
• MalfunctionMar 26, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SIMPULSE SOLO WAS USED ON THE PATIENT TO IRRIGATE A LEFT ARM WOUND. THE DEVICE WAS THEN DISCARDED. ONE WEEK LATER WHEN THE PATIENT RETURNED FOR AN ADDITIONAL WOUND IRRIGATION IT WAS DISCOVERED THAT THE TIP HAD BROKEN OFF OF THE PREVIOUS DEVICE AND WAS IN THE WOUND. THE ENTIRE PIECE WAS RETRIEVED AND THERE WERE NO FRAGMENTS LEFT BEHIND. THE PATIENT DID NOT SHOW ANY ADVERSE REACTION TO THE DETACHED PIECE AND IT WAS REMOVED FROM THE WOUND WITHOUT ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE WOUND WAS THEN IRRIGATED WITH NO FURTHER ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7370688 ↗