Key Surgical Vascular Loops VL-205Recalls & reported problems
Key Surgical, Inc. · Vascular Loops, Sterile, Red, Maxi, 18-inch long, 2 per package · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849771030874), received between Mar 3, 2023 and Mar 31, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2023Break; Break
THE USER FACILITY REPORTED VIA MEDWATCH REPORT #4900240000-2023-8024 THAT WHEN THEY PUT THEIR RUMEL TOURNIQUET ON THEIR VASCULAR LOOP, THE VASCULAR LOOP BROKE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16654925 ↗MalfunctionMar 3, 2023Break
WE USED THE MAXI LOOP THAT WAS OPENED SEPARATELY FROM THE PACKAGE. WHEN WE TRIED TO PUT THE REMEL ON IT, IT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16477841 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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