AIRCASTRecalls & reported problems across all models
Djo, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one AIRCAST model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 7 models of AIRCAST by Djo, LLC in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between May 23, 2016 and Apr 1, 2025 — classified as 5 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fire” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AIRCAST recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 17, 2019Open, Classified
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Z-1985-2019 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported AIRCAST problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Fire2
- Sparking2
- Patient Device Interaction Problem1
- Smoking1
- Temperature Problem1
Patient problems
- No Patient Involvement4
- Electric Shock2
- Burn(s)1
- No Known Impact Or Consequence To Patient1
- Pain1
- Pressure Sore/Ulcer1
- Thrombosis1
AIRCAST models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AIRCAST 3011-PLSLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- AIRCAST 30B-SSLEEVE, LIMB, COMPRESSIBLE4 reports
- AIRCAST 30B-BSLEEVE, LIMB, COMPRESSIBLE2 reports
- AIRCAST 10A01Pack, hot or cold, water circulating1 report
- AIRCAST 51APack, hot or cold, water circulating1 report
- AIRCAST 51A11BPack, hot or cold, water circulating1 report
- AIRCAST 3040SLEEVE, LIMB, COMPRESSIBLE1 report
Recent AIRCAST adverse event reports
The 10 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT WAS REPORTED BY THE PATIENT THAT THE UNIT IS GIVING ELECTRIC SHOCKS AND PAIN THAT LASTED UP TO TWO WEEKS.
Patient problems: Electric Shock; Pain
MAUDE report 21748994 ↗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 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem
IT WAS REPORTED THAT, CUFFS WERE APPLIED AT THE SURGERY CENTER AND PATIENT EDUCATION WAS PERFORMED AT THE SURGERY CENTER AS WELL ON INSTRUCTION FOR USING THE DEVICES. THE ANKLE LEAKED AT THE TOES AND OTHER UP TOP OF ANKLE. SHE LATER DEVELOPED FROST BITE LEADING TO WOUNDS AND PLASTIC SURGERY.
Patient problems: Burn(s)
MAUDE report 19136648 ↗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 ↗MalfunctionJul 27, 2020Fire; Fire
IT WAS REPORTED THAT THE "VENAFLOW ELITE UNIT CAUGHT FIRE IN THE OPERATING ROOM. NO ONE WAS INJURED AND THE FIRE DEPARTMENT WAS CALLED TO THE SCENE. THE MACHINE WAS CLEARED TO GO BACK INTO THE BUILDING BY THE FIRE MARSHALL AFTER THE SCENE WAS CLEARED." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10326530 ↗MalfunctionMar 2, 2020Fire; Fire
IT WAS REPORTED THAT THE "VENAFLOW UNIT IN OR (OPERATING ROOM) BEGAN SMOKING AND STARTED ON FIRE. THE UNIT WAS PLUGGED IN AT THE TIME, BUT NOT IN USE ON A PATIENT."
Patient problems: No Patient Involvement
MAUDE report 9774031 ↗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 ↗InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "MOTOR WILL NOT TURN OFF DOES NOT WORK INTERMITTENTLY..CUSTOMER STATED THAT IT CAUSE A BLOOD CLOT". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME.
Patient problems: Thrombosis
MAUDE report 7419462 ↗InjuryMay 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "PATIENT DEVELOPED GRADE 3 ULCER ON LOWER ANKLE/FOOT. POSSIBLY CAUSED BY THE TUBING ON THE CUFF ". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Patient problems: Pressure Sore/Ulcer
MAUDE report 5673697 ↗
Other Djo, LLC products
All Djo, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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