SIMPULSERecalls & reported problems across all models
Davol Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 10 models of SIMPULSE by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Jun 12, 2024 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Break” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SIMPULSE problems
Device problems
- Break14
- Device Contamination with Chemical or Other Material14
- Detachment of Device or Device Component11
- Fluid/Blood Leak10
- Inability to Irrigate5
- Corroded2
- Manufacturing, Packaging or Shipping Problem2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Patient Involvement18
- No Consequences Or Impact To Patient11
SIMPULSE models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SIMPULSE 0057570LAVAGE, JET8 reports
- SIMPULSE 0067570LAVAGE, JET7 reports
- SIMPULSE 0067010LAVAGE, JET7 reports
- SIMPULSE 0067700LAVAGE, JET5 reports
- SIMPULSE 0067590LAVAGE, JET5 reports
- Simpulse 0067621LAVAGE, JET5 reports
- Simpulse 0057621LAVAGE, JET5 reports
- Simpulse 0067730LAVAGE, JET3 reports
- SIMPULSE 0067600LAVAGE, JET2 reports
- Simpulse 0057730LAVAGE, JET2 reports
Recent SIMPULSE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, THE SIMPULSE SOLO SUCTION/IRRIGATION DEVICE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LEAKAGE OCCURRED AT THE PERFORATION IN THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519077 ↗MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, THE SIMPULSE SOLO SUCTION/IRRIGATION DEVICE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LEAKAGE OCCURRED AT THE PERFORATION IN THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519076 ↗MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, THE SIMPULSE SOLO SUCTION/IRRIGATION DEVICE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LEAKAGE OCCURRED AT THE PERFORATION IN THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519074 ↗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 ↗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 ↗MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A LEFT KNEE STAGE REVISION JOINT REPLACEMENT PROCEDURE, THE SIMPULSE SOLO IRRIGATOR WAS USED AND THE SURGEON NOTICED THAT THE PURPLE SMALL TIP (SHOWERHEAD FACEPLATE) WAS NO LONGER ATTACHED PRIOR TO CLOSURE. THE MISSING PIECE WAS ATTEMPTED TO BE LOCATED IN THE SURGICAL SITE; HOWEVER, WAS UNABLE TO BE FOUND. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16380399 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Davol Inc. products
All Davol Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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