STATLOCK CV0226Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741081552), received between Nov 7, 2018 and Nov 25, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10907166 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE SEVENTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10907040 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10907028 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906992 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906936 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE SIXTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906916 ↗
• MalfunctionSep 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN THE NUMBER OF SAFETY REPORTS RELATED TO THE PLASTIC PIECE OF THE STATLOCK DETACHING FROM THE ADHESIVE BACKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THIS OCCURRED WITH 7 DEVICES, FOUR OF WHICH WERE RETURNED TO MANUFACTURER. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518765 ↗
• MalfunctionNov 7, 2018Defective Device

  IT WAS REPORTED THAT THE BLUE ASSEMBLY COULD NOT BE USED NORMALLY, AND THEN REMOVED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047649 ↗