Jay Fusion Jay Flow Fluid/Jay Air/ Jay Fluid w/CryoRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00016958056563), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Degraded; Degraded

  ON OCTOBER 24, 2025, THE DEALER CALLED TO REPORT THAT THE AIR BLADDER IS LEAKING AIR, AND THE DEALER THINKS IT IS LEAKING AROUND THE VALVE. CUSTOMER SERVICE AGENT HAD THE DEALER DO A SUDS TEST. DEALER STATED THE VALVE WAS NOT TIGHT, TIGHTENED THE VALVE AND THERE WERE NO BUBBLES. DEALER STATES THAT IT IS THE ONLY PLACE IT WOULD LEAK AIR. HE DID NOT CHECK THE SEAMS, NOT THE BLADDER ITSELF. HE ADDED AIR TO DETERMINE IF IT WOULD HOLD AIR. PER THE DEALER, THE USER STATES SHE GOT THE CUSHION BECAUSE "SHE ALREADY HAD BED SORES" AND NOW, THEY ARE WORSE. THE AIR STARTED LEAKING 2 WEEKS AGO. THE USER WENT TO A WOUND CARE CENTER ON THE PREVIOUS DATE AND IS DUE TO GO BACK IN 2 WEEKS AND WOULD BE SEEING A NURSE. USER IS 5'5, 235 LBS. AND BORN (B)(6). DEALER STATES HE WILL GIVE IT 24 HOURS TO SEE IF THE LEAK HAS STOPPED. THERE WERE NO UPDATES AND NO FURTHER COMPLAINTS MADE ON THIS ISSUE, SO IT CAN BE CONCLUDED THAT THE TIGHTENING OF THE VALVE RESOLVED THE ISSUE.

  Patient problems: Localized Skin Lesion

  MAUDE report 23650925 ↗