SHERPA NX BALANCED SB7EBU40SHRecalls & reported problems
Medtronic, Inc. · CATHETER SB7EBU40SH SB 7F 100CM EB40 · Class 2
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 00613994837493), received between Jan 2, 2020 and Jan 2, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
A 7 FR SHERPA BALANCED GUIDE CATHETER WAS INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A PORTION OF THE DEVICE DETACHED DURING PREP. THE DEVICE MANIPULATED DURING PREP. AN ATTEMPT WAS MADE TO INSERT THE DEVICE INTO THE INTRODUCER. THE DEVICE WAS NOT USED IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9537413 ↗
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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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