STATLOCK D10120CERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741081644), received between Aug 17, 2016 and Nov 9, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE SWELLING AND BLISTERING IN HER ARM. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Swelling

  MAUDE report 8057209 ↗
• MalfunctionFeb 17, 2017Device Slipped

  FACILITY REPORTED THAT THE "CLAMSHELL" ON THE STATLOCK DID NOT LOCK PROPERLY AND OPENED AFTER CLOSING IT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6341859 ↗
• MalfunctionOct 25, 2016Mechanics Altered

  HEALTH PROFESSIONAL REPORTED THAT THE CLOSURE ON THE DIALYSIS STATLOCK IS NOT HOLDING, THUS THE DIALYSIS CATHETERS ARE NOT PROPERLY FIXED. FACILITY IS USING ADDITIONAL ADHESIVE TAPE ON THE LOCK TO FIX THE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6056070 ↗
• MalfunctionAug 17, 2016Product Quality Problem

  IT WAS REPORTED THAT ALLEGEDLY THE PLASTIC HOLDER OF STATLOCK DIALYSIS STABILIZATION DEVICE GOES ON VERY EASILY - SPRING VERY OFTEN BY THEMSELVES - WHICH IS NOT GOOD FOR THE STABILIZATION OF THE DIALYSIS CATHETER . PREVIOUSLY THIS WENT ON VERY HARD AND HAVE CERTAINLY NOT MYSELF OPENED - HENCE THE DIALYSIS CATHETER FALLS OUT PERMANENTLY. WHEN A PACK ((B)(4) PIECES) OF THESE ERRORS IN HALF OF THE STABILIZATION DEVICES OCCURS - WHICH IS NOT ACCEPTABLE FOR THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5883289 ↗
• MalfunctionAug 17, 2016Mechanics Altered

  IT WAS REPORTED THAT THE PLASTIC HOLDERS OF THE STATLOCK DIALYSIS STABILIZATION DEVICES GO ON EASILY BUT HAVE ALLEGEDLY SPRUNG OPEN BY THEMSELVES. FACILITY REPORTED THAT AFTER IMPLANTATION OF A CATHETER, THEY USED A STATLOCK DIALYSIS STABILIZATION DEVICE TO AFFIX THE CATHETER. THEY REPORTED THAT THE STATLOCK "LOCK" DID HOLD THE CATHETER BUT THEN POPPED OPEN ALLOWING THE DIALYSIS CATHETER TO "FALL OUT". NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5883284 ↗