POSEY 2551Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10190676004956), received between Oct 7, 2022 and Sep 18, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTING COMPLAINT ON PRODUCT#: 2551. CUSTOMER REPORTS THAT IN ICU THAT A PATIENT WAS ABLE TO GET THEIR HAND OUT OF THE RESTRAINT & ALMOST SELF EXTUBATED 2-TIMES. THIS IS A 2ND COMPLAINT TO RMA#: (b)(4). (b)(6).

  Patient problems: Unintended Extubation

  MAUDE report 50819037 ↗
• MalfunctionJul 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unintended Extubation

  MAUDE report 25862146 ↗
• MalfunctionJul 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unintended Extubation

  MAUDE report 25862009 ↗
• MalfunctionJul 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unintended Extubation

  MAUDE report 25861992 ↗
• MalfunctionJul 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unintended Extubation

  MAUDE report 25861960 ↗
• InjuryFeb 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2551. CUSTOMER STATES THAT THE PATIENT WAS ABLE TO BITE OFF & SWALLOW THE PRODUCT LABEL. RESULTED IN A BRONCHOSCOPY PROCEDURE TO REMOVE THE LABEL. CUFF WAS DISPOSED OF AND IS NOT AVAILABLE FOR RETURN.

  Patient problems: Airway Obstruction

  MAUDE report 21333059 ↗
• MalfunctionNov 13, 2024Device Slipped; Device Slipped

  CUSTOMER STATES THAT PRODUCT 2551 IS COMING LOOSE AND THE PATIENT IS ABLE TO UNCLIP THE PRODUCT. CUSTOMER STATES PATIENTS ARE ABLE TO USE THE PRODUCT AS LEVERAGE TO UNCLIP THEM. THEN, IF THE PATIENT IS SHAKING AND PULLING THE CLIP WILL SLIP DOWN AND GET LOOSER OVER TIME. NO PATIENT INCIDENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676150 ↗
• MalfunctionJan 9, 2024Device Slipped; Device Slipped

  CUSTOMER IS REPORTING COMPLAINT ON PRODUCT # 2551. CUSTOMER IS SAYING THEY HAVE HAD SEVERAL EXTUBATIONS INVOLVING THE 2551. CUSTOMER STATES THAT THEY FEEL THE TIGHTENING BUCKLE HAS BEEN LOOSENING OVER TIME. LOT# 3289T029.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479945 ↗
• MalfunctionNov 17, 2023Device Slipped; Device Slipped

  SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162038 ↗
• MalfunctionSep 6, 2023Device Slipped; Device Slipped

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2551. (B)(6). CUSTOMER STATES THAT THE MALE END OF THE QUICK RELEASE BUCKLE IS SLIPPING. THIS IS THE 3RD OCCURANCE IN THE IDN WITHIN 3 WEEKS. ADVISE TECH SERVICES ONCE THE INSPECTION RESULTS ARE AVAILABLE. PRODUCT LOT# 3145T038 & 3118T037.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690922 ↗
• MalfunctionAug 30, 2023Device Slipped; Device Slipped

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2551. (B)(6). CUSTOMER STATES THAT THE MALE END OF THE QUICK RELEASE BUCKLE IS SLIPPING. THIS IS THE 2ND OCCURANCE IN THE IDN WITHIN 3 WEEKS. ADVISE TECH SERVICES ONCE THE INSPECTION RESULTS ARE AVAILABLE. PRODUCT LOT# 3145T038.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651501 ↗
• MalfunctionAug 21, 2023Device Slipped; Device Slipped

  PLEASE SHARE THIS WITH THE COMPLAINT EVALUATORS: I DISCUSSED TYING A KNOT JUST BELOW THE QR BUCKLE PER IFU. THE NURSE MANAGER'S RESPONSE WAS "WHAT IS THE POINT OF THE BUCKLE? WHICH IS COMPLETELY UNDERSTANDABLE. SHE SAID THAT WOULD NOT WORK BECAUSE THEY MUST UNTIE IT OFTEN TO ADJUST THE LENGTH TO ACCOMMODATE THE PATIENTS POSITION IN THE BED. I, THEN, SUGGESTED A SLIP KNOT FOR QUICK RELEASE. SHE SAID THAT WOULD NEVER HAPPEN. AS A THIRD OPTION, I SUGGESTED UTILIZING THE INNER LOOP ON THE DETACHABLE PIECE TO SHORTEN THE STRAP, ADJUSTING THE ANGLE OF THE QR TO HELP PREVENT SLIPPAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586699 ↗
• MalfunctionJan 6, 2023Protective Measures Problem; Patient Device Interaction Problem

  CUSTOMER STATES: PATIENT SELF-EXTUBATED WITHIN TWO MINUTES OF ME CHECKING BOTH RESTRAINTS AND WITHIN 5 SECS OF ME LEAVING THE ROOM (BECAUSE I EXPECTED THE RESTRAINT TO FUNCTION AS IT SHOULD). AFTER THE SELF-EXTUBATION, I NOTED THAT THE VELCRO ON THE LEFT WRIST RESTRAINT FAILED, ALLOWING THE PT TO REACH HIS ETT. I REPLACED BOTH RESTRAINTS ONCE I DISCOVERED THE ISSUE. I AM VERY CONFIDENT THAT WAS A DEVICE FAILURE BECAUSE THE VELCRO FAILED IN THE EXACT SAME WAY ON AN ENTIRELY NEW RESTRAINT AT 0405. I WITNESSED THE VELCRO FAILURE THREE TIMES IN THE SPAN OF 15 SECONDS. KILLIAN WAS IN THE ROOM WITH ME WHEN THIS HAPPENED. HE WITNESSED THE VELCRO FAIL THE SECOND TWO TIMES.

  Patient problems: Unintended Extubation

  MAUDE report 16113005 ↗
• MalfunctionOct 7, 2022Break; Break

  TIDI WAS NOTIFIED PER FDA REPORT (B)(4) OF CUSTOMER ISSUE WITH PART 2551. CUSTOMER REPORTED THEY HAD THE RESTRAINT ON THEIR PATIENT, PATIENT ON OCCASION WAS AGGRESSIVE. A NURSE WAS HELPING TURN PATIENT WHEN THE NURSE UNCLIPPED THE SOFT WRIST RESTRAINT ON PATIENT'S LEFT ARM, THEY FOUND THE CLIP TO BE BROKEN. NO HARM WAS REPORTED FOR THIS PATIENT. THE NURSE PROMPTLY REPLACED THE RESTRAINT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15564574 ↗