ALLEN 103001 (REF A-70701)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00615521002701), received between Mar 29, 2022 and Aug 13, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (9 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Sep 20, 2022Terminated

   the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

   Z-0176-2023 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241199 ↗
• MalfunctionJul 17, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25855058 ↗
• MalfunctionApr 7, 2026Unintended Movement

  BAXTER RECEIVED A REPORT STATING THAT C-FLEX HEAD POSITIONING PACKAG HAD MOVED WHILE IN THE LOCKED POSITION. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807950 ↗
• MalfunctionFeb 17, 2026Unintended Movement

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HD POS DEVICE ONLY WAS NOT HOLDING ITS POSITION. DEVICE HAD MOVEMENT ON THE HOUSING ADAPTER DURING CERVICAL SPINE PROCEDURE. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366257 ↗
• MalfunctionFeb 13, 2026Unintended Movement

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HD POS DEVICE ONLY HAD MOVED WHILE IN THE LOCKED POSITION. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334099 ↗
• MalfunctionNov 3, 2025Unintended Movement; Unintended Movement

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER WAS NOT HOLDING ITS POSITION, IT WAS SLIPPING. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458857 ↗
• MalfunctionAug 8, 2025Unintended Movement; Unintended Movement

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER DEVICE WAS NOT HOLDING ITS POSITION, PATIENT'S HEAD WAS STILL MOVING. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751538 ↗
• MalfunctionAug 1, 2025Positioning Failure; Positioning Failure

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER KNOB THAT LOCK HORIZONTAL TRANSLATION ARE STUCK AND THE C-FLEX SLIDES FREELY. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689061 ↗
• MalfunctionJun 20, 2025Positioning Failure; Positioning Failure

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER DEVICE WAS NOT HOLDING ITS POSITION. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22300869 ↗
• MalfunctionApr 29, 2025Positioning Failure; Positioning Failure

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER JOINT WAS NOT HOLDING ITS POSITION. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927756 ↗
• MalfunctionApr 29, 2025Positioning Failure; Positioning Failure

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER JOINT WAS NOT HOLDING CORRECT AMOUNT OF WEIGHT. THE DEVICE WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926622 ↗
• MalfunctionMar 12, 2025Positioning Failure; Positioning Failure

  BAXTER RECEIVED A REPORT STATING THAT THE C-FLEX WILL NOT HOLD ITS POSITION. THE DEVICE WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586843 ↗
• MalfunctionNov 29, 2024Positioning Failure; Positioning Failure

  BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER WAS NOT HOLDING THE PATIENTS HEAD IN THE LOCK POSITION. THE ISSUE WAS DISCOVERED IN THE OR AFTER PLACING THE PATIENT IN POSITION. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810927 ↗
• InjuryDec 29, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ALLEN C-FLEX HEAD POSITIONER ALLEGEDLY CAUSED A PRESSURE INJURY TO A PATIENT¿S CHIN. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION REPORTED. ON (B)(6) 2023, THE C-FLEX WAS USED DURING A POSTERIOR CERVICAL CASE WITH A MIZUHO FACE MASK PAD AND MIZUHO FACE PLATE. THE CUSTOMER WAS SENT BAXTER/ALLEN DISPOSABLE FACE MASKS, HOWEVER, THE BAXTER SALES REPRESENTATIVE WHO WAS PRESENT AT THE TIME OF THE SURGERY DID NOT RECALL SEEING THEM OR THAT THEY WERE USED WITH THE C-FLEX. ON (B)(6) 2023, THE CUSTOMER REPORTED TO THE BAXTER SALES REPRESENTATIVE THAT WHEN THE PATIENT WAS TAKEN OUT OF THE POSITIONER, HE HAD DEVELOPED A SEVERE PRESSURE INJURY ON HIS CHIN. THE CUSTOMER WAS UNCERTAIN HOW THIS HAPPENED, BUT STATED THE PATIENT WAS IN A PRONE POSITION FOR 9 PLUS HOURS. ADDITIONALLY, THE BAXTER SALES REPRESENTATIVE STATED THE PATIENT WAS PLACED IN TRENDELENBURG AT SOME POINT FOR THE SURGERY ITSELF AND IMAGING; HOWEVER, THE CUSTOMER DENIED THIS. THE BAXTER SALES REPRESENTATIVE ALSO NOTED A LOT OF SURGICAL TAPE WAS USED TO POSITION THE PATIENT AND LIMIT MOVEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION INCLUDING BUT NOT LIMITED TO THE STAGE OF THE PRESSURE INJURY, TREATME

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 18418988 ↗
• InjuryDec 28, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE ALLEN C-FLEX HEAD POSITIONER ALLEGEDLY CAUSED A PRESSURE INJURY TO A PATIENT¿S CHIN. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION REPORTED. ON (B)(6) 2023, THE C-FLEX WAS USED DURING A POSTERIOR CERVICAL CASE WITH A MIZUHO FACE MASK PAD AND MIZUHO FACE PLATE. THE CUSTOMER WAS SENT BAXTER/ALLEN DISPOSABLE FACE MASKS, HOWEVER, THE BAXTER SALES REPRESENTATIVE WHO WAS PRESENT AT THE TIME OF THE SURGERY DID NOT RECALL SEEING THEM OR THAT THEY WERE USED WITH THE C-FLEX. ON (B)(6) 2023, THE CUSTOMER REPORTED TO THE BAXTER SALES REPRESENTATIVE THAT WHEN THE PATIENT WAS TAKEN OUT OF THE POSITIONER, HE HAD DEVELOPED A SEVERE PRESSURE INJURY ON HIS CHIN. THE CUSTOMER WAS UNCERTAIN HOW THIS HAPPENED, BUT STATED THE PATIENT WAS IN A PRONE POSITION FOR 9 PLUS HOURS. ADDITIONALLY, THE BAXTER SALES REPRESENTATIVE STATED THE PATIENT WAS PLACED IN TRENDELENBURG AT SOME POINT FOR THE SURGERY ITSELF AND IMAGING; HOWEVER, THE CUSTOMER DENIED THIS. THE BAXTER SALES REPRESENTATIVE ALSO NOTED A LOT OF SURGICAL TAPE WAS USED TO POSITION THE PATIENT AND LIMIT MOVEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION INCLUDING BUT NOT LIMITED TO THE STAGE OF THE PRESSURE INJURY, TREATME

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 18416043 ↗
• MalfunctionSep 29, 2022Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  IT WAS REPORTED THAT DURING USE OF A C-FLEX POLAR HEAD POSITIONER THE DEVICE MOVED AND WOULD NOT HOLD IN PLACE. THERE WAS NO ALLEGATION OF INJURY FROM THE EVENT. IT IS NOTED THIS OCCURRED IN THE OR SETTING, AT THE START OF A PROCEDURE, AND THERE WAS NO INDICATION THE DEVICE WAS GOING TO FAIL. THIS EVENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508217 ↗
• MalfunctionMar 29, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE C-FLEX HEAD POSITIONER DEVICE, THE DEVICE SUDDENLY DROPPED RESULTING IN THE UNINTENDED MOVEMENT OF THE PATIENT. PHOTOGRAPHS PROVIDED BY THE CUSTOMER SHOW THE PATIENT SUSTAINED A LACERATION ABOVE THE RIGHT EAR AND WHAT RESEMBLES A BRUISE ABOVE THE LEFT EAR. MEDICAL INTERVENTION FOR THE INJURY WAS NOT REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE EVENT WERE UNSUCCESSFUL. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM REF (B)(4).

  Patient problems: Bruise/Contusion; Head Injury; Laceration(s)

  MAUDE report 13939421 ↗