MEDLINE MDS601MSQRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389145708), received between May 15, 2026 and Jun 2, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Pressure Problem” (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. 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.

• MalfunctionJun 2, 2026Pressure Problem

  ACCORDING TO THE FACILITY, ON 5/5/2026, CVICU NURSE MANAGER (B)(6), RN AT (B)(6) HOSPITAL REPORTED THAT THEY HAVE A PATIENT WHO WAS WEARING OUR MEDIUM SEQUENTIAL DVT SLEEVE AND EXPERIENCED DTI. WOUNDS APPEARED ON THE LOWER LEGS AND THE SLEEVE WAS REMOVED. I MET WITH THE REPORTING NURSE, AND THE INTERPRETATION IS THE PATIENT HAD WOUNDS ALREADY ON THE LEGS HOWEVER THE TUBING MAY HAVE CONTRIBUTED TO IT BECAUSE OF THE SLEEVE PLACEMENT.

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 25363082 ↗
• InjuryMay 15, 2026Unexpected Therapeutic Results

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2026 THE "RN NOTED BRUISING AND DISCOLORATION TO PATIENT'S CALF UNDER SCD SLEEVE." PER THE FACILITY, "RIGHT LOWER EXTREMITY WITH SCATTERED AREAS OF LINEAR MAROON AND DARK PURPLE DISCOLORATION, MAINLY ON POSTERIOR, MEDIAL, AND LATERAL SIDES. SKIN IS INTACT. LIKELY DUE TO PRESSURE FROM SCDS." FOLLOWING DISCOVERY OF THE "DEEP TISSUE INJURY" SCD USE WAS DISCONTINUED AND "SWEEN24 LOTION" WAS APPLIED TO THE LOWER EXTREMITY. PER THE FACILITY, THE INDIVIDUAL HAS SINCE PASSED AWAY UNRELATED TO THE REPORTED DEVICE COMPLAINT.

  Patient problems: Bruise/Contusion; Skin Discoloration

  MAUDE report 25191800 ↗