VAPR ARCTIC 225029Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705022526), received between Aug 17, 2018 and Sep 25, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE VAPR ARCTIC SUCTION ELECT DOME DEVICE SUCTION DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302881 ↗
• MalfunctionSep 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE VAPR ARCTIC SUCTION ELECT DOME DEVICE SUCTION DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302712 ↗
• MalfunctionJun 20, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A HIP SURGICAL PROCEDURE ON (B)(6) 2024 THE VAPR ARCTIC SUCTION ELECT DOME TIIP WAS NOT WORKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576166 ↗
• MalfunctionMay 10, 2024Use of Device Problem; Infusion or Flow Problem; Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE VAPR ARCTIC SUCTION ELECT DOME DEVICE SUCTION STOPPED WORKING. THERE WAS NO REPORTS OF DELAYS IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286765 ↗
• MalfunctionSep 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A HIP ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR ARCTIC SUCTION ELECTRODE WITH DOME TIP DEVICE WAS CLOGGED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495358 ↗
• MalfunctionOct 8, 2021Output Problem; Output Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR ARCTIC SUCTION ELECT DOME DEVICE STOPPED WORKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598707 ↗
• MalfunctionMay 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A HIP ARTHROSCOPY THE COAGULATION FUNCTION OF THE VAPR ARCTIC SUCTION ELECTRODE WITH DOME TIP WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091873 ↗
• MalfunctionSep 18, 2019Break; Break

  IT WAS REPORTED THAT HIP SCOPE: (B)(6), (B)(6) HOSPITAL, WHEN THEY OPENED UP THE PACKAGE, AND THE HANDLE WAS BROKEN. A SECOND ELECTRODE WAS OPENED AND COMPLETED THE PROCEDURE . NO ADVERSE EVENT TO THE PATIENT, NO DELAY IN THE SURGERY. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084538 ↗
• MalfunctionJan 21, 2019Fracture; Fracture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING HIP ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE VAPR ARCTIC SUCTION ELECT DOME ELECTRODE DEVICE BROKE OFF DURING USE. THEY DID NOT OPEN ANOTHER ITEM, AND THE CASE WAS COMPLETED WITHOUT IT. THE ITEM WAS DISCARDED. NO REPORTED ADVERSE EVENT TO PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264747 ↗
• MalfunctionJan 21, 2019Suction Failure; Suction Failure

  IT WAS REPORTED BY THE SALES REP THAT DURING A HIP SCOPE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR ARCTIC SUCTION ELECT DOME DEVICE HAD NO SUCTION. ACCORDING TO THE REPORTER, STAFF AND SURGEON ADVISED THAT NEPTUNE AND TUBING CHECKED OUT FINE AND FELT THE ISSUE WAS WITH THE ELECTRODE NOT SUCTIONING PROPERLY OR AT ALL. IT WAS REPORTED THAT ANOTHER ELECTRODE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8263729 ↗
• MalfunctionJan 18, 2019Suction Failure; Suction Failure

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUCTION ON THE VAPR ARCTIC SUCTION ELECT DOME DEVICE STOPPED WORKING ENTIRELY. THE DEVICE WAS REMOVED AND THE SURGERY WAS COMPLETED WITH A REPLACEMENT OF IDENTICAL DESCRIPTION. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261629 ↗
• MalfunctionSep 11, 2018Melted; Melted

  IT WAS REPORTED BY THE SALES REP THAT DURING A HIP PROCEDURE WHEN PRESSING THE BUTTON TO ARTICULATE ON THE CUSTOMER'S VAPR ARCTIC SUCTION ELECTRODE WITH DOME TIP, THE DEVICE WOULD NOT ARTICULATE. THE SALES REP STATED THAT THE TIP OF THE ELECTRODE APPEARS TO BE BENT AND MELTED A LITTLE. THE SALES REP STATED THAT THE SURGEON DID NOT USE A CANNULA WITH THE DEVICE AND THAT THE DEVICE WAS NOT NEAR METAL. THE SALES REP STATED THAT THE SURGEON WAS NOT HOOKING OR GRABBING TISSUE WITH THE DEVICE. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A COOL PULSE ELECTRODE USING THE SAME GENERATOR WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TEN MINUTE DELAY. THE SALES REP STATED THAT THE GENERATOR SETTINGS WERE SET A DEFAULT AND THAT NEPTUNE WAS USED FOR SUCTION. THE SALES REP WAS UNSURE HOW LONG THE DEVICE WAS ON BEFORE FAILURE BUT STATED THAT THE DEVICE WAS USED INTERMITTENTLY. THE SALES REP REPORTED THAT THERE WAS NO SPARKING OR ARCING AND THAT THE DEVICE WAS NOT BURIED IN TISSUE. THE SALES REP STATED THAT THE ELECTRODE IS NOT A REPROCESSED DEVICE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864768 ↗
• MalfunctionAug 19, 2018Break; Break

  IT WAS REPORTED THAT DURING THE HIP PROCEDURE, AT THE STAGE OF THE CAPSULOTOMY BY USING THE ELECTRODE VAPR ARCTIC, THE ELECTRODE TIP BROKE OFF WHERE THERE IS THE PART THAT ALLOWS THE DEVICE TO MOVE. THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. NO CONSEQUENCES FOR THE PATIENT ARE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796277 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ARTHROSCOPIC HIP SCOPE PROCEDURE, THE SURGEON NOTICED THAT THE ELECTRODE WAS NOT RESPONSIVE ABOUT 30 MINUTES INTO THE PROCEDURE, ACCORDING TO THE REPORT, THE ELECTRODE'S TIP ARTICULATED AND WAS NOT WORKING PROPERLY. IT WAS FURTHER REPORTED THAT WHEN VIEWED WITH THE C-ARM, IT WAS CLEAR THAT THE TIP WAS BROKEN. IT WAS REPORTED THAT THE SURGEON OPENED ANOTHER ARCTIC ELECTRODE TO FINISH THE CASE. IT WAS REPORTED THAT THE PATIENT WAS FINE POST-SURGERY. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793441 ↗