Circul8 Pro, Pair 08-0027Recalls & reported problems
Precision Medical Products, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00194832000021), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2022No Apparent Adverse Event; No Apparent Adverse Event
HEMATOMA FORMED ON THE RIGHT LEG UNDER THE COMPRESSION SLEEVE. THE ATTENDING PHYSICIAN HAD TO DRAIN THE HEMATOMA AND CHANGE THE PATIENT'S ANTICOAGULANT MEDICATION.
Patient problems: Hematoma
MAUDE report 13865375 ↗
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- RAW MATERIAL 30MDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE52 reports
- Kendall 84021BCardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- AIRCAST 3011-PLDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- Kendall 84021PCardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.