VersaStep VS101505Recalls & reported problems
Covidien LP · Dilator and Cannula with Radially Expandable Sleeve · Class 2
Data updated Oct 13, 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 20884521082868), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
Device problems
- Difficult to Insert1
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.
MalfunctionAug 27, 2018Difficult to Insert; Difficult to Insert
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY DURING A LAPAROSCOPIC GASTRIC BYPASS, MULTIPLE DIFFERENT 5MM INSTRUMENTS WERE INTRODUCED AND CAUGHT IN THE MIDDLE PORTION OF THE CANNULA. THIS ONLY HAPPENED ON THE FIRST 4-5 PASSES THROUGH THE CANNULA AND THEN IT NO LONGER OCCURRED. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7819319 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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