RapidVac SE3690Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884524001555), received between Mar 13, 2018 and Jan 30, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Failure to Calibrate; Electrical Shorting; Failure to Calibrate; Electrical Shorting

  ACCORDING TO THE REPORTER, CURRENT LEAKAGE EXCEEDS OVER 2MA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607186 ↗
• MalfunctionJul 13, 2023Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD UNUSUAL SOUND OR NOISE. THE PROCEDURE WAS ABORTED. THE EQUIPMENT WAS TESTED BEFORE USING IT ON THE PATIENT, WHICH DID NOT WORK. THE HOSPITAL SMOKE EXTRACTOR WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322034 ↗
• MalfunctionJan 25, 2023Decrease in Suction; Structural Problem; Intermittent Energy Output

  DURING A SURGICAL PROCEDURE, THIS SMOKE EVACUATOR (ONE OF TWO THAT FAILED DURING SAME PROCEDURE) WAS WORKING INTERMITTENTLY DURING THE CASE. UNIT WAS RESTARTED AND THE SAME ISSUE WAS OCCURRING. THE UNIT WAS REMOVED FROM SERVICE AND A SECOND UNIT WAS SET UP. ALSO HAVE NOTED THAT THE HANDPIECES FOR THE UNITS DO NOT CAPTURE SMOKE VERY WELL AND THE HANDPIECES ARE LARGE WHICH MAKES IT HARD FOR THE SURGEONS TO SEE WHAT THEY ARE DOING. NO ADVERSE OUTCOME TO PATIENT, THERE WAS AN INCREASE IN THE AMOUNT OF SMOKE IN THE OR ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240044 ↗
• MalfunctionJan 25, 2023Decrease in Suction; Structural Problem; Intermittent Energy Output

  DURING A SURGICAL PROCEDURE, THIS SMOKE EVACUATOR (TWO OF TWO THAT FAILED DURING SAME PROCEDURE) WAS WORKING INTERMITTENTLY DURING THE CASE. UNIT WAS RESTARTED AND THE SAME ISSUE WAS OCCURRING. THE UNIT WAS REMOVED FROM SERVICE. ALSO HAVE NOTED THAT THE HANDPIECES FOR THE UNITS DO NOT CAPTURE SMOKE VERY WELL AND THE HANDPIECES ARE LARGE WHICH MAKES IT HARD FOR THE SURGEONS TO SEE WHAT THEY ARE DOING. NO ADVERSE OUTCOME TO PATIENT, THERE WAS AN INCREASE IN THE AMOUNT OF SMOKE IN THE OR ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240030 ↗
• MalfunctionMar 29, 2022Defective Device; Protective Measures Problem

  IN (B)(6) 2022, THERE WERE A TOTAL OF FIVE SMOKE EVACUATION SYSTEMS THAT WERE INTERMITTENTLY NOT WORKING DURING SURGICAL PROCEDURES. ALL CONNECTIONS WERE CHECKED AND POWER CYCLED/RESTARTED; HOWEVER, SYSTEMS CONTINUED TO NOT ALWAYS ENGAGE DURING THE SURGICAL PROCEDURE. EARLY FEBRUARY, THREE SMOKE EVACUATION UNITS WERE REPORTED TO MEDTRONIC WITH INTERMITTENT OPERATION ISSUES. BIOMED REPORTED TO MEDTRONIC THAT A FOURTH SMOKE EVACUATION SYSTEM IS HAVING INTERMITTENT OPERATION ISSUES. BIOMED REPORTED A FIFTH UNIT TO MEDTRONIC WITH INTERMITTENT OPERATION ISSUES. THE SMOKE EVACUATORS WERE PURCHASED IN 2020 AND WERE ALL PAST THEIR ONE YEAR WARRANTY. WE REPLACED THE FIVE SMOKE EVACUATORS WITH NEW ONES. MEDTRONIC HAS NOT GIVEN ANY FOLLOW UP OF CAUSE OF INTERMITTENT OPERATION. IN (B)(6), WE HAVE AN ADDITIONAL THREE SMOKE EVACUATION SYSTEMS THAT WILL NEED TO BE REPLACED BECAUSE OF THE "INTERMITTENT OPERATION" ISSUE. THESE UNITS WERE ALL PURCHASED IN 2020 WITH RECENT PMS. EVENT: SMOKE EVACUATION WAS INTERMITTENTLY WORKING DURING A SURGICAL PROCEDURE. TEAM CHECKED ALL CONNECTIONS AND POWER CYCLED/RESTARTING SYSTEM. SYSTEM CONTINUED TO NOT ALWAYS ENGAGE WHEN CAUTERY USED. BIOMEDICAL ENGINEERING C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937860 ↗
• MalfunctionFeb 15, 2022Break; Overheating of Device; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Break; Overheating of Device; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A TOTAL JOINT PROCEDURE, THE SMOKE EVACUATOR WOULD STOP VACUUMING. IF THE UNIT WAS TURNED OFF THEN ON IT WOULD START-UP FOR A SHORT AMOUNT OF TIME. TROUBLESHOOTING WAS DONE WITH THE UNIT IN THE BIOMED DEPARTMENT USING THE SAME SETTINGS- THE FT10 SET WITH A MONOPOLAR PENCIL SET AT CUT ¿ 50 AND COAG -50 AND THE EVACUATOR ON MAXIMUM SUCTION. THE RAPIDVAC WAS OVERHEATING AND WOULD TURN OFF FAN. PROCEDURE WAS DELAYED 20 MINUTES. THERE WAS LONGER TIME UNDER ANESTHESIA AND OPEN WOUND. STAFF UNHOOKED ALL DISPOSABLE ITEMS AND REPLACED THE TOWER WITH A SECOND UNIT. PROCEDURE WAS COMPLETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13534066 ↗
• MalfunctionFeb 2, 2022Electrical Power Problem; Electrical Shorting; Electrical Power Problem; Electrical Shorting

  ACCORDING TO THE REPORTER, THE UNIT WAS BLOWING FUSES AND HAD LEAKAGE CURRENT OF 490 MICROAMPERE (UA).

  Patient problems: Insufficient Information

  MAUDE report 13426976 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY, IT WAS CONFIRMED THAT HEMOSTASIS WAS ACHIEVED. THERE WAS BLEEDING SEVERAL HOURS AFTER SURGERY. THE PROCEDURE WAS APPLIED TO EXTERNAL COMPRESSION. THERE WAS NO ANEMIA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13213381 ↗
• MalfunctionDec 28, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD WRENCH LIGHT INDICATOR ERROR ON. IT WAS NOTED THAT THERE WAS A DELAY OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13095588 ↗
• MalfunctionOct 19, 2021Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD HIGH LEAKAGE CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657171 ↗
• MalfunctionNov 13, 2019Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, THE UNIT WAS IN STANDBY MODE AND IT SUCKED 19 LITERS PER MINUTE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9319295 ↗
• MalfunctionJul 12, 2019Output Problem

  WHILE USING THE COVIDIEN SMOKE EVACUATOR, IT WAS NOT WORKING CONSISTENTLY. SMOKE EVAC JUST STOPS WORKING WITH NO EXPLANATION. STAFF IN ROOM BREATHING IN LARGE AMOUNTS OF PLUME FROM CASE. ALL CABLES, CONNECTIONS, FILTERS, AND THE BOVIE ITSELF CHECKED; NO APPARENT REASON FOR SMOKE EVAC TO BE WORKING ONLY INTERMITTENTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784755 ↗
• MalfunctionDec 27, 2018Self-Activation or Keying; Suction Problem; Self-Activation or Keying; Suction Problem

  ACCORDING TO THE REPORTER, SOMETIMES THE UNIT'S SUCTION STARTS ON ITS OWN AND WHEN THEY WANT TO TRIGGER THE SUCTION, IT WOULD NOT RESPOND. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8200034 ↗
• MalfunctionApr 20, 2018Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING SURGERY, THE DEVICE WOULD NOT SHUT OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7448732 ↗
• MalfunctionMar 13, 2018False Alarm; No Audible Prompt/Feedback; Adverse Event Without Identified Device or Use Problem; False Alarm; No Audible Prompt/Feedback; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE UNIT WOULD NOT MAKE A NOISE WHEN PENCIL WAS ACTIVATED. THE PATIENT INCURRED A MINOR BURN ON INNER THIGHS. THERE WAS NO MEDICAL INTERVENTION NEEDED.

  Patient problems: Burn(s)

  MAUDE report 7335781 ↗