VersaStep Plus VSR100812PRecalls & reported problems
Covidien LP · Radially Expandable Sleeve · Class 2
All models of VersaStep Plus (7)
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 10884521084179), received between Aug 28, 2018 and Aug 28, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC HYSTERECTOMY, WHEN THE SURGEON MOVED IN AND OUT OF THE MIRROR VIEWING NEEDLE, IT CAUGHT ON THE VALVE OF THE DEVICE AND THE DEVICE GOT OUT OF THE ABDOMINAL WALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7822892 ↗MalfunctionAug 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC HYSTERECTOMY, WHEN THE SURGEON MOVED IN AND OUT OF THE MIRROR VIEWING NEEDLE, IT CAUGHT ON THE VALVE OF THE DEVICE AND THE DEVICE GOT OUT OF THE ABDOMINAL WALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7822811 ↗
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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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