RapidVac SE3695Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884524001753), received between Jan 14, 2019 and Nov 27, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Fire; Smoking; Noise, Audible; Intermittent Energy Output; Fire; Smoking; Noise, Audible; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD A POPPING SOUND. ELECTRICAL BURNING SMELL CAME OUT OF THE UNIT AND WAS NOT OPERATIONAL. BIOMED FOUND SOOT ON THE BOTTOM VENTS OF THE UNIT BUT NO OBSERVABLE DAMAGES OR BROKEN HOUSING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799460 ↗
• MalfunctionSep 15, 2022Unintended Power Up; Unintended Power Up

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD INADVERTENT ACTIVATION. USED A NEW GENERATOR WITH THE SAME HANDPIECE AND WORKED SUCCESSFULLY. AFTER TROUBLE SHOOTING FOUND THAT IT WAS AN OPERATOR ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429129 ↗
• MalfunctionFeb 14, 2022Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING SERVICING, THE INSULATION TEST FAILED AT THE ANNUAL ELECTRICAL SAFETY TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524299 ↗
• MalfunctionNov 30, 2021Break; Fire; Material Integrity Problem; Break; Fire; Material Integrity Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE UNIT HAD SEVERE BURNING AND DAMAGE TO MAIN CABLE PROXIMAL TO UNIT: DAMAGE TO IEC MAIN INPUT CONNECTOR SUCH AS MELTED PLASTIC AND NEUTRAL PIN DAMAGE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE. THE MEDTRONIC INITIAL VISUAL INVESTIGATION SHOWED THAT THE INLET AREA WAS BURNED AND PLASTIC INSULATIONS MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12890023 ↗
• MalfunctionSep 16, 2021Communication or Transmission Problem; Electrical Shorting; Communication or Transmission Problem; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING USE, SAFETY TEST FAILED DUE TO EXCESSIVE LEAKAGE CURRENT AND THE KEYPAD WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484911 ↗
• MalfunctionNov 4, 2019Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, DEVICE SELF-ACTIVATES WITHOUT PUSHING THE START BUTTON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9276373 ↗
• MalfunctionOct 4, 2019Overheating of Device; Smoking; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Intermittent Energy Output; Overheating of Device; Smoking; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Intermittent Energy Output

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE OVERHEATED WHILE THE ENGINE WAS MOVING. AFTER, A LOUD NOISE WAS HEARD, THE DEVICE WENT OUT AND THERE WAS A LOT OF SMOKE CAME OUT OF THE DEVICE. AN ELECTRIC FIRE EXTINGUISHER WAS USED ON THE MACHINE. THE PATIENT INHALED THE SMOKE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9154599 ↗
• MalfunctionJun 26, 2019Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE STAYED ON WHEN FOOT SWITCH WAS RELEASED OR EVEN WHEN THE FOOT SWITCH WAS ALREADY REMOVED. A NEW UNIT WAS USED TO COMPLETE THE CASE. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8733294 ↗
• MalfunctionFeb 5, 2019Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WENT INTO A HIGH VACUUM MODE AS SOON AS IT WAS TURNED ON AND COULD NOT BE STOPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8305851 ↗
• MalfunctionJan 14, 2019Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING TESTING, WHEN THE FORCEPS BUTTON ON THE FRONT PANEL IS CHOSEN THE DEVICE MAINTAINS THE SUCTION PERMANENTLY. THE SUCTION SHOULD BE ACTIVATED ONLY AT THE MOMENT WHEN A DIATHERMAL BURN IS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8246186 ↗