Catheter Stabilization Device NG0120Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10801741076173), received between Oct 18, 2017 and Aug 26, 2026 — classified as 1 death, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459866 ↗
• MalfunctionAug 24, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420780 ↗
• MalfunctionOct 15, 2025Loss of or Failure to Bond; Component Misassembled; Loss of or Failure to Bond; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT REPEATEDLY, THE ADHESIVE LIFTS FROM THE NOSE AND PEELS BACK AFTER 4 HOURS, THE TAPE STICKS TO ITSELF WHEN YOU WRAP IT AROUND THE NASOGASTRIC BUT THEN THE TUBE SLIDES THROUGH IT. THIS WAS A HUGE RISK AS IT ALLOWS THE TUBE TO SLIDE OUT, INCREASING THE RISK OF ASPIRATION OF THE TUBE FEED AND ALSO THE LOSS OF A TUBE AS IT CAN SLIP OUT AND REQUIRE A NEW ONE TO BE REINSERTED. THIS ISSUE WAS REPORTED BY 6 DIFFERENT NURSES OVER THE PAST FEW DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278019 ↗
• MalfunctionOct 8, 2025Device Dislodged or Dislocated; Component Misassembled; Device Dislodged or Dislocated; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT REPEATEDLY, THE ADHESIVE LIFTS FROM THE NOSE AND PEELS BACK AFTER 4 HOURS, THE TAPE STICKS TO ITSELF WHEN THEY WRAP IT AROUND THE NASOGASTRIC, BUT THEN THE TUBE SLIDES THROUGH IT. THIS WAS A HUGE RISK AS IT ALLOWS THE TUBE TO SLIDE OUT, INCREASING THE RISK OF ASPIRATION OF THE TUBE FEED AND ALSO THE LOSS OF A TUBE AS IT COULD SLIP OUT AND REQUIRE A NEW ONE TO BE REINSERTED, THIS ISSUE WAS REPORTED BY 6 DIFFERENT NURSES OVER THE PAST FEW DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246736 ↗
• MalfunctionSep 10, 2025Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER HAD AS A BACKUP, THE NOTIFICATION OF THE WAREHOUSE AREA SINCE 1 PIECE OF THE STATLOCK WAS MISSING THAT CORRESPONDS TO THE INVOICE 9019864213 TO PLEASE SUPPORT US WITH THE FOLLOW-UP OF THE MISSING PIECE. THE PRODUCT WAS BACK LABELED IN THE CEDIS AT THE CJ LEVEL, BUT NOT AT THE PIECE LEVEL AND 1 EA WAS MISSING, IT WAS OF QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016087 ↗
• MalfunctionNov 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE NASOGASTRIC STATLOCKS WERE NOT STICKING TO THE PATIENTS EVEN AFTER USING THE PREPARATION PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586986 ↗
• InjuryJun 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER QUESTIONED IF THERE WAS ANY INFORMATION WITH EVIDENCE BASED DATA ON HOW OFTEN NG STATLOCK SHOULD BE REPLACED DAILY OR WHEN SOILED. THE CUSTOMER ALSO QUESTIONED FOR VIDEO OR PHOTO DIAGRAM ON HOW TO SECURE THE TAPE BECAUSE THE NUMBER OF PRESSURE INJURY RELATED INJURIES FROM THE STATLOCK INCREASED SIGNIFICANTLY IN THE PAST 13 MONTHS WITHIN THE SAME UNIT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 14643515 ↗
• DeathDec 17, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLINICIAN WAS USING THE NASOGASTRIC STABILIZATION DEVICE TO SECURE A DOBHOFF TUBE THAT HAD A SMALLER LUMEN FOR LONG TERM FEEDINGS. THE MANUFACTURER AND CATALOG NUMBER OF THE DOBHOFF TUBE WAS UNKNOWN. IT WAS REPORTED THAT WHEN THE CLINICIAN FOUND THE PATIENT EXPIRED, THE STABILIZATION DEVICE TAPE WAS STILL SECURED TO THE PATIENT'S NOSE, BUT THE TUBE WAS NO LONGER ATTACHED, AND THE PATIENT HAD BEEN ASPIRATED. THE FACILITY REQUESTED TO UNDERSTAND IF THE DEVICE WAS APPROVED FOR USE WITH SMALLER LUMEN FEEDING TUBES OR IF AN ALTERNATE DEVICE SHOULD BE USED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 13DEC2021, THE FACILITY CONTACT NURSE STATED THAT THE CAUSE OF DEATH WAS ASPIRATION. A CLINICAL FOLLOW UP EMAIL WAS SENT TO COMPLAINANT ON 17DEC2021 REQUESTING ADDITIONAL EVENT AND PATIENT DETAILS. A FOLLOW UP EMAIL RESPONSE WAS RECEIVED ON 20DEC2021 FROM THE COMPLAINANT STATING HE DOES NOT HAVE ANY ADDITIONAL INFORMATION TO PROVIDE. DESPITE GOOD FAITH EFFORTS NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 13025674 ↗
• MalfunctionAug 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK DID NOT STAY IN PLACE AND OFTEN RESULTED IN UNINTENTIONAL REMOVAL OF NASOGASTRIC TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294457 ↗
• MalfunctionMay 21, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS ONE MISSING PIECE IN THE PACKAGE OF STATLOCK NASOGASTRIC. IT WAS STATED THAT THE CUSTOMER REJECTED THE DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867337 ↗
• MalfunctionMar 25, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK HOLDER NOT SECURED THE TUBE AND THE TUBE MIGRATES OR PULLS OUT, WHICH NEEDED REPLACEMENT AND DOESN'T STICK TO THE NOSE. PER FOLLOW UP ON 06JUN2021, CUSTOMER STATED THAT THE PROBLEM SEEMS TO BE THAT THE ADHESIVE WRAP DID NOT ENCIRCLE TO TUBE AS MUCH AS OUR PREVIOUS PRODUCT DID. SO ONCE THE PATIENT HAD DISCHARGE FROM THE NOSE, IT LOOSENS THE ADHESIVE PORTION AROUND THE TUBE EVEN THOUGH WE USE ALCOHOL PRIOR TO PLACEMENT AND THEN THE TUBE BECOMES DISLODGED. THIS HAD HAPPENED MULTIPLE TIMES AND PREVIOUS PRODUCT WRAPPED AROUND THE TUBE MULTIPLE TIMES SO IF SOME ADHESION DID LOOSEN, IT WAS STILL ABLE TO STAY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567921 ↗
• MalfunctionAug 7, 2020Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE ANALYTICAL CERTIFICATE THEY SENT COINCIDES WITH THAT OF THE BOX, BUT THE PIECE INDICATES ANOTHER EXPIRATION DATE. THE BOX INDICATES AN EXPIRATION OF 05-28-2022 AND THE PIECES HAVE AN EXPIRATION OF JUNE 2022.

  Patient problems: No Patient Involvement

  MAUDE report 10382475 ↗
• MalfunctionOct 18, 2017Failure To Adhere Or Bond

  IT WAS REPORTED THAT THE STATLOCK NASOGASTRIC PEELED OFF DESPITE USING SKIN PROTECTANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958149 ↗