Key Surgical Vascular Loops VL-206Recalls & reported problems
Key Surgical, Inc. · Vascular Loops, Sterile, Blue, Maxi, 18" long, 2/pkg · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00849771030881), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2020Material Separation; Material Separation
KEY SURGICAL RECEIVED FDA MEDWATCH REPORT MW5096967 ON OCTOBER 29, 2020. THE REPORT STATED THAT AN 18" BLUE MAXI VASCULAR LOOP (DETERMINED BY KEY SURGICAL TO BE VL-206) BROKE INTO THREE PIECES DURING SURGERY. THE LOOP WAS PLACED INTO PATIENT'S ABDOMEN AND BROKE INTO 3 PIECES. TWO PIECES WERE EASILY RETRIEVED AND THE THIRD PIECE WAS FOUND IN THE FILTER OF THE NEPTUNE SUCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10905047 ↗
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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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