AIRCAST 30B-SRecalls & reported problems
Djo, LLC · VENAFLOW ELITE SYSTEM, WITH S-MODE · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912306553), received between Jun 27, 2019 and Dec 6, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Sparking” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Sparking2
- Adverse Event Without Identified Device or Use Problem1
- Smoking1
Patient problems
- No Patient Involvement2
- Electric Shock1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UNIT WAS PLUGGED IN, THE UNIT WAS NOT ON THE PATIENT. THE NURSE WAS CLEANING IT WITH A WIPE AND IT STARTED HEATING UP AND THEN SHE SAW A SPARK ON THE VENAFLOW AND THEN THE ELECTRICAL SHOCK WAS CAUSED. THE INCIDENT HAPPENED AT 10 PM ON (B)(6) 2024, WE WERE NOTIFIED ON NOVEMBER 11 2024 AT 11:46 PST. THE NURSE WAS TREATED, SHE WAS TAKEN TO THE EMERGENCY ROOM.
Patient problems: Electric Shock
MAUDE report 20872493 ↗MalfunctionJul 27, 2020Sparking; Sparking
IT WAS REPORTED THAT " THE DEVICE SHORTED OUT AND SHOT SPARKS. THEY SAID THERE WERE NO INJURIES, BUT THE UNIT TRIPPED THE CIRCUIT BREAKER FOR THE ROOM IT WAS IN. THERE IS A HOLE IN THE POWER CORD WHERE IT LOOKS LIKE THE WIRES TOUCHED." DEVICE NOT RECEIVED BY MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Patient problems: No Patient Involvement
MAUDE report 10326531 ↗MalfunctionSep 12, 2019Smoking; Smoking
IT WAS REPORTED THAT THE UNIT WAS "SMOKING, NOTHING APPEARED TO PRECIPITATE". NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9009692 ↗MalfunctionJun 27, 2019Sparking; Sparking
IT WAS REPORTED THAT "ACCORDING TO THE CLINICAL STAFF, THEY SAW SPARKS COMING FROM THE MACHINE." THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8740505 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.