Medline MSCBUB2822VLRecalls & reported problems
Medline Industries, Inc. · VALVELESS, CUSHION,BUBBLE,BARI,28X22 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10197344014354), received between Sep 7, 2026 and Sep 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
- Gas/Air Leak1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Gas/Air Leak
This VMSR report summarizes 1 malfunction event that occurred between July 1 and September 30, 2024. The account reported that bariatric bubble cushions (b)(6) were losing air, resulting in patients bottoming out after only a few days of use. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883966 ↗MalfunctionSep 8, 2026Deflation Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679689 ↗MalfunctionSep 7, 2026Material Split, Cut or Torn; Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649517 ↗
Other CUSHION, FLOTATION devices
- MEDLINE MSCBUB1818Medline Industries, Inc. · CUSHION, FLOTATION10 reports
- MEDLINE MSCBUB1818VLMedline Industries, Inc. · CUSHION, FLOTATION4 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1011CRoho, Inc. · Cushion, Flotation3 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1010CRoho, Inc. · Cushion, Flotation3 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS910CRoho, Inc. · Cushion, Flotation2 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS89CRoho, Inc. · Cushion, Flotation2 reports
- ROHO HIGH PROFILE Single Compartment Cushion 1R109CRoho, Inc. · Cushion, Flotation2 reports
- MEDLINE MSCBUB2822Medline Industries, Inc. · CUSHION, FLOTATION2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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