Kendall SCD 9528Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253016284), received between Apr 10, 2024 and Aug 15, 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.

• InjuryAug 15, 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 7/17 AND NOTICED THAT A HEMATOMA HAD FORMED ON THE MORNING OF 7/25. 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 22814301 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED LAST YEAR, THEY HAD A VISITOR WHO SUSTAINED A FALL WITH SIGNIFICANT INJURIES AFTER TRIPPING OVER THE CLEAR SCD TUBING THAT EXTENDS BETWEEN THE MACHINE AND THE PATIENT. AS PART OF THE PROCESS IMPROVEMENT PLAN, THEY IDENTIFIED THE LENGTH OF THE SCD TUBING (APPROXIMATELY 5 FEET) TO BE A RISK FACTOR FOR ADDITIONAL OCCURRENCES. THE PATIENTS ONLY WEAR THE SCDS WHILE IN BED AND ARE OFF WHEN THE PATIENT IS SITTING IN A CHAIR OR WHILE AMBULATING. WHEN THE TUBING IS DISCONNECTED, IT OFTEN SLIDES OFF OF THE BED AND ONTO THE FLOOR. THEY HAVE EVALUATED WAYS TO SECURE THE TUBING AND CORDS BUT HAVE NOT BEEN SUCCESSFUL DUE TO INFECTION CONTROL/PREVENTION METHODS. THEY HAVE ALSO EDUCATED THE STAFF TO BE EXTRA MINDFUL OF ALL CORDS AND TUBING. SOMETIMES IT IS NOT STAFF WHO DISCONNECT THE DEVICES, BUT THE PATIENT OR FAMILY MEMBERS. THE CUSTOMER IS ASKING IF IT IS POSSIBLE TO REDUCE THE LENGTH OF THE SCD TUBING. ADDITIONAL INFORMATION RECEIVED STATED THE VISITOR THAT FELL SUSTAINED A COMMINUTED LEFT SUPERIOR PUBIC RAMUS FRACTURE AND NON-DISPLACED FRACTURE OF THE LEFT ISHIUM. HE WAS ADMITTED BUT DIDN'T HAVE ANY SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19078878 ↗