DONJOY 11-1316-0-02000Recalls & reported problems
Djo, LLC · PAD, KNEE, MANUAL COLD · Class 2
All models of DONJOY (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912016582), received between Mar 27, 2018 and Mar 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2018Fluid/Blood Leak; Fluid/Blood Leak
COMPLAINT RECEIVED THAT ALLEGES "FOLLOWING AN OPERATION FOR A TOTAL KNEE REPLACEMENT, AS PART OF RECOVERY I WAS GIVEN A KNEE PAD FILLED WITH ICY WATER TO HELP REDUCE THE SWELLING, ITEM TO BE USE AT HOME. IT SPRUNG A LEAK BUT UNFORTUNATELY THE WATER CAME OUT IN A JET AND LANDED FURTHER AWAY ON CUSTOMER LAPTOP. LAPTOP DESTROY AND HAD TO BUY A NEW ONE".
Patient problems: No Information
MAUDE report 7374838 ↗
Other Pack, hot or cold, water circulating devices
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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