SIMPULSE 0057570Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741065255), received between Dec 27, 2019 and Aug 28, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE PLUS SHOWER HEAD TIPS SUCTION/IRRIGATION DEVICE WAS USED DURING INCISION AND DRAINAGE (I&D) OF TOE WHICH THE FLUID IN A 3 L NS BAG HANGING OFF AN IV POLE WOULD NOT STOP FLOWING THROUGH DEVICE AS SOON AS THE BAG IS SPIKED AT TIMES. IT WAS REPORTED THAT USUALLY THEY SET THE PSI NO GREATER THAN 120 MMHG. IT WAS ALSO REPORTED THAT FLUID CAME OUT OF THE EXHAUST LINE AND THE PRESSURE RELIEF VALVE POPPED OUT. THE DEVICE WORKED FINE SOMETIMES THROUGHOUT THE CASE AND THEN WOULD FAIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630981 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE PLUS SHOWER HEAD TIPS SUCTION/IRRIGATION DEVICE WAS USED DURING INCISION AND DRAINAGE (I&D) OF KNEE WHICH THE FLUID IN A 3 L NS BAG HANGING OFF AN IV POLE WOULD NOT STOP FLOWING THROUGH DEVICE AS SOON AS THE BAG IS SPIKED AT TIMES. IT WAS REPORTED THAT USUALLY THEY SET THE PSI NO GREATER THAN 120 MMHG. IT WAS ALSO REPORTED THAT FLUID CAME OUT OF THE EXHAUST LINE AND THE PRESSURE RELIEF VALVE POPPED OUT. THE DEVICE WORKED FINE SOMETIMES THROUGHOUT THE CASE AND THEN WOULD FAIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630979 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE PLUS SHOWER HEAD TIPS SUCTION/IRRIGATION DEVICE WAS USED DURING INCISION AND DRAINAGE (I&D) OF KNEE WHICH THE FLUID IN A 3 L NS BAG HANGING OFF AN IV POLE WOULD NOT STOP FLOWING THROUGH DEVICE AS SOON AS THE BAG IS SPIKED AT TIMES. IT WAS REPORTED THAT USUALLY THEY SET THE PSI NO GREATER THAN 120 MMHG. IT WAS ALSO REPORTED THAT FLUID CAME OUT OF THE EXHAUST LINE AND THE PRESSURE RELIEF VALVE POPPED OUT. THE DEVICE WORKED FINE SOMETIMES THROUGHOUT THE CASE AND THEN WOULD FAIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630978 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE PLUS SHOWER HEAD TIPS SUCTION/IRRIGATION DEVICE WAS USED DURING INCISION AND DRAINAGE (I&D) OF ABDOMINAL WOUND WHICH THE FLUID IN A 3 L NS BAG HANGING OFF AN IV POLE WOULD NOT STOP FLOWING THROUGH DEVICE AS SOON AS THE BAG IS SPIKED AT TIMES. IT WAS REPORTED THAT USUALLY THEY SET THE PSI NO GREATER THAN 120 MMHG. IT WAS ALSO REPORTED THAT FLUID CAME OUT OF THE EXHAUST LINE AND THE PRESSURE RELIEF VALVE POPPED OUT. THE DEVICE WORKED FINE SOMETIMES THROUGHOUT THE CASE AND THEN WOULD FAIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630824 ↗
• MalfunctionAug 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE PLUS SHOWER HEAD TIPS SUCTION/IRRIGATION DEVICE WAS USED DURING INCISION AND DRAINAGE (I&D) OF SCROTUM WHICH THE FLUID IN A 3 L NS BAG HANGING OFF AN IV POLE WOULD NOT STOP FLOWING THROUGH DEVICE AS SOON AS THE BAG IS SPIKED AT TIMES. IT WAS REPORTED THAT USUALLY THEY SET THE PSI NO GREATER THAN 120 MMHG. IT WAS ALSO REPORTED THAT FLUID CAME OUT OF THE EXHAUST LINE AND THE PRESSURE RELIEF VALVE POPPED OUT. THE DEVICE WORKED FINE SOMETIMES THROUGHOUT THE CASE AND THEN WOULD FAIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623805 ↗
• MalfunctionAug 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2022, A PIECE OF HAIR WAS FOUND INSIDE THE STERILE PACKAGE OF BARD/DAVOL SIMPULSE PLUS DEVICE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190800 ↗
• MalfunctionApr 29, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  AS REPORTED, DURING THE SETUP OF A PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL SIMPULSE PLUS IRRIGATOR LEAKED SALINE BECAUSE THE CONNECTOR NEAR THE SALINE SOLUTION INFLOW WAS POORLY CONNECTED. IN ADDITION, WHEN PRESSURE WAS APPLIED, THE CONNECTION SUDDENLY CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744751 ↗
• MalfunctionDec 27, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE OPENING THE SIMPULSE VARICARE IRRIGATOR PACKAGE, FOREIGN MATERIAL LIKE HAIR WAS NOTED INSIDE OF THE SEALED PACKAGE. THE PACKAGE WAS NOT OPENED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9527235 ↗