Kendall SCD 74021 (UDI 10192253016147)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253016147), received between Nov 13, 2024 and Jul 25, 2025 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS: A HEMATOMA WAS DISCOVERED DURING THE USE OF SCD700, AND AN INCISION WAS REQUIRED FOR RETRIEVAL. I HAVE BEEN USING IT SINCE (B)(6) AND NOTICED THAT A HEMATOMA HAD FORMED ON THE MORNING OF (B)(6). THE PATIENT HAD EDEMA EVEN BEFORE USING THE SCD700 SYSTEM. IT IS UNKNOWN HOW MUCH EDEMA IT WAS. CURRENTLY, THE TREATMENT IS OVER AND THE PATIENT'S CONDITION IS STABLE, AND SCD IS NOT BEING USED. IT SEEMS THAT THE ALARM DOES NOT GO OFF DURING USE, BUT I ASKED FOR AN INVESTIGATION OF THE MAIN UNIT AND CONSUMABLES TO SEE IF THERE IS A POSSIBILITY THAT THE PRESSURE HAS TEMPORARILY INCREASED. THE USAGE PERIOD WAS 9 DAYS.

  Patient problems: Hematoma

  MAUDE report 22617878 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS THAT THE USE OF THE SCD COMFORT SLEEVE CAUSED PERONEAL NERVE PALSY. ON TUESDAY, (B)(6), SHE UNDERWENT SPINE SURGERY AT THE ORTHOPEDIC DEPARTMENT AND RETURNED TO THE WARD. DECREASED MANUAL MUSCLE STRENGTH MEASUREMENT (MMT) AND HYPOESTHESIA UPON RETURNING TO THE ROOM. PERHAPS BECAUSE THE WOUND IS PAINFUL, PAINKILLERS ARE USED IN THE OPERATING ROOM. AFTER 3 HOURS, STRONG COMPLAINTS OF HYPESTHESIA. THE DOCTOR'S REPORT WAS THAT THE PATIENT WAS DIAGNOSED WITH PERONEAL NERVE PALSY. A PLANTAR SLEEVE IS USED DURING SURGERY, AND A SLEEVE BELOW THE KNEE IS USED AFTER SURGERY. THE FOOT PUMP WAS TURNED ON AND STARTED AFTER OBSERVATION OF VITAL SIGNS AND THE LIKE. AT THE 3 HOUR TIME OF OBSERVATION, THERE WAS MMT, SENSORY CONFIRMATION, AND PAIN, AND SINCE BLOCK INJECTIONS WERE NOT GIVEN, PAIN RELIEF WAS PERFORMED. FOUR HOURS LATER, IT WAS REPORTED TO THE DOCTOR, AND DURING THE EXAMINATION, HE POINTED OUT THAT THE LOWER LIMB SLEEVE WAS COMPRESSING THE FIBULA HEAD AND HE NOTICED THAT COMPRESSION IT WAS FROM THE LOWER LIMB SLEEVE OF THE FOOT PUMP. THE CAUSE WAS DETERMINED TO BE "INAPPROPRIATE USE OF A FOOT PUMP TO PREVENT VENOUS EMBOLISM". AS A COUNTERMEASURE, THE PUBLIC WAS INFORME

  Patient problems: Hypoesthesia; Nerve Damage

  MAUDE report 20678414 ↗