RapidVacRecalls & reported problems across all models

We found 3 models of RapidVac by Covidien LP in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Mar 13, 2018 and Nov 27, 2024 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (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. 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

Most reported RapidVac problems

RapidVac models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RapidVac SE3690

  APPARATUS, EXHAUST, SURGICAL
  15 reports
• RapidVac SE3695

  APPARATUS, EXHAUST, SURGICAL
  10 reports
• RapidVac SE3690ZD

  APPARATUS, EXHAUST, SURGICAL
  1 report

Recent RapidVac adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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