MEDLINE MSCBUB2822Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193489086198), received between Sep 24, 2026 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Gas/Air Leak; Material Split, Cut or Torn

  It was reported that 5/6 have leaked from seams. Customer states he has tested cushions under water and has noticed where the air is leaking from.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897864 ↗
• MalfunctionSep 24, 2026Material Puncture/Hole; Unintended Deflation

  This VMSR report summarizes 2 malfunction events that occurred during Q1 2025 (January 1, 2025 through March 31, 2025). The account reported that seat cushions were received deflated upon delivery. The customer indicated that the affected cushions were unusable upon receipt and requested replacement product. The complaint involved two cases of cushions that allegedly failed to maintain inflation. The customer also advised that previously received defective units had been discarded prior to reporting the issue. Lot number, serial number, and sales order information were requested, and a call tag was issued to facilitate return of available samples for evaluation. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883016 ↗