MITEK 242027Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705029044), received between Mar 25, 2024 and Apr 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE NATURE OR CAUSE OF THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT IN CONNECTION WITH THIS ISSUE. NO INJURIES WERE REPORTED, AND THERE WAS NO NEED FOR MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL RELEVANT DETAILS HAVE ALREADY BEEN DISCLOSED, AND NO FURTHER INFORMATION WAS PROVIDED ABOUT THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823195 ↗
• MalfunctionMar 16, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR ROTATOR CUFF TEAR OF SHOULDER JOINT, IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,70,167CW_ MITEK SHEATH DEVICE, A DEDICATED PRODUCT FOR THE PUREVUE CAMERA SYSTEM, CAME OFF AND BROKE AT THE PART CONNECTING THE SHAFT AND COCK. IT WAS REPORTED THAT THE SURGEON PREPARED ANOTHER SET AND SUCCESSFULLY COMPLETED THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607356 ↗
• MalfunctionSep 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR WITH A PUREVUE CAMERA SYSTEM, THE SURGEON ATTEMPTED TO CONNECT THE SHE_2RSTCK_5.9,70,167CW_ MITEK SHEATH DEVICE AND THE OBT_BUTTON_4.0,167CW_MITEK OBTURATOR DEVICE, BUT IT WAS DIFFICULT TO INSERT THE OBTURATOR SMOOTHLY INTO THE SHEATH. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO REMOVE THE OBTURATOR FROM THE SHEATH. THEREFORE, THE SHEATH AND OBTURATOR DEVICES WERE REPLACED WITH ANOTHER SHEATH AND OBTURATOR. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952970 ↗
• MalfunctionApr 2, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE DUAL STOPCOCK SHEATH 5.9MM X 70 DEG X 167MM (MITEK LOCK) WAS BROKEN. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019513 ↗
• MalfunctionMar 25, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE TORNADO MICRO SHAVER HANDPIECE WAS OVERHEATING AND THE SHEATH WITH 2 ROTATING STOPCOCKS COMPATIBLE WITH MITEK LOCK 5.9MM X 70 DEG X 167MM DEVICE WAS BROKEN. IT WAS REPORTED THAT THE DEVICES WERE FROM THE CADAVERIC LAB AND NOT USED IN SURGERY. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18967399 ↗