SenSight™ B31030 (UDI 00763000451868)Recalls & reported problems
Medtronic, Inc. · ACCY B31030 EXT TNLR DBS PAPER LJ55 · Class 1
- 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 00763000451868), received between Aug 18, 2026 and Aug 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Break; Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307594 ↗
Other INSTRUMENT, SURGICAL, NON-POWERED devices
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- WECK IPN006432Teleflex Incorporated · INSTRUMENT, SURGICAL, NON-POWERED3 reports
- 3.3mm Mini-Bolt VUE 21133Monteris Medical Inc · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- NA 365538Medtronic, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- NA 1120Advanced Neuromodulation Systems, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- RELIANCE LITe 48060500Stryker Corporation · INSTRUMENT, SURGICAL, NON-POWERED1 report
- NeuroBalloon™ 7CBD10Integra LifeSciences Switzerland Sàrl · INSTRUMENT, SURGICAL, NON-POWERED1 report
- AESCULAP FV002RAesculap AG · INSTRUMENT, SURGICAL, NON-POWERED1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.