Hemo-Force MDS601MDRecalls & reported problems
Medline Industries, Inc. · GARMENT,MEDLINE,DVT,INT,CALF,FOAM,MED · Class 2
- 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 10080196561513), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loss of or Failure to Bond
It was reported that Sequential Compression Device (SCD) sleeves were often alarming and the issue would resolve upon changing the product (the SCD sleeve), and upon review it was found that the item was defective and not providing an adequate seal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932085 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.