SolidAIRity Flex 4.1500.2DSRecalls & reported problems
Securisyn Medical, LLC · Oral Endotracheal Tube Stabilizer Dual Strap, Fits ETT Sizes 7.0mm-8.5mm (I.D.) / 9.3mm-11.8mm (O.D.) · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00860009077928), received between Jun 7, 2023 and Jun 23, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Device Dislodged or Dislocated1
- Material Too Rigid or Stiff1
Patient problems
- Choking1
- Laceration(s)1
- Unspecified Respiratory Problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON TWO OCCASIONS THE POSITIONING MECHANISM WOULD NOT HOLD IN PLACE ALLOWING THE ETT TO "FLOAT" FROM SIDE TO SIDE.
Patient problems: Unspecified Respiratory Problem
MAUDE report 17195284 ↗InjuryJun 23, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff
WE ARE SEEING ON OCCASION, THE UPPER LIP OF THE PATIENT GETTING PINCHED BY THE LARGE FOAM PAD UNDER THE POSITIONING TRACK. THE INJURY OCCURRED FROM THE PAD PRESSION AGAINST THE PATIENT'S TEETH.
Patient problems: Laceration(s)
MAUDE report 17195280 ↗InjuryJun 7, 2023Break; Break
S-FLEX HAD BROKEN WHERE THE TOWER MEETS THE LATERAL SLIDE.
Patient problems: Choking
MAUDE report 17083133 ↗
Other Device, Fixation, Tracheal Tube devices
- AnchorFast 9799Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 death49 reports
- AnchorFast SlimFit 9787Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall4 reports
- AnchorFast Guard 9800Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall4 reports
- AnchorFast Guard Select 9700Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 report
- Medline DYNJMBRC2Medline Industries, Inc. · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 report
- Medline DYNJMBRC4BMedline Industries, Inc. · DEVICE, FIXATION, TRACHEAL TUBE1 recall0 reports
- AnchorFast 9799Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE21 reports
- HUDSON RCI IPN914324Teleflex Incorporated · DEVICE, FIXATION, TRACHEAL TUBE6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.