Sterion® Vessel Loop 011021PBXRecalls & reported problems
Aspen Surgical Products, Inc. · Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures · Class 1
Data updated Oct 16, 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 00840113229260), received between Oct 31, 2024 and Dec 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging2
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.
MalfunctionDec 9, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "IMPERFECT SEAL OF THE POUCH. -OPEN CHANNEL / LARGE SEALING VOID IN THE POUCH SEAL. -INNER POUCH WAS CAUGHT IN THE OUTER POUCH SEAL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760096 ↗MalfunctionOct 31, 2024Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "THE STERILE PACKAGING IS OPEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579437 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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