Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-03-26 | Z-1776-2024 | Class I | Open, Classified | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.Distribution: Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. | 3286 applications. | code info di |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-02-09 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 3 |
| 2021-06-29 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 3 |
| 2019-09-30 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 1 |
| 2016-08-18 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 0 |
| 2014-12-15 | NAI | No action indicated | Medtronic Navigation, Inc. | 0 |
| 2014-02-19 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 5 |
| 2012-09-06 | NAI | No action indicated | Medtronic Navigation, Inc. | 0 |
| 2012-05-01 | NAI | No action indicated | Medtronic Navigation, Inc. | 0 |
| 2011-03-24 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 1 |
| 2010-05-07 | WL | Warning Letter | Medtronic Navigation, Inc. | — |
| 2010-02-04 | OAI | Official action indicated | Medtronic Navigation, Inc. | 9 |
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