Visualase Thermal Therapy System — Class II medical device recall Z-3251-2018
Terminated recall by Medtronic Navigation, Inc., reported 2018-10-03, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal
| Recall number | Z-3251-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2018-06-01 |
| Classified | 2018-09-26 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2022-02-02 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI |
| Countries outside the US | CH, DE, GB, IL, NL |
| Quantity | 161 |
| UPC / GTIN / UDI-DI | 00643169655935, 00643169792890, 00643169905719 |
| Serial numbers | 071217-001, 100811-001, 110317-001, 110603.001, 110720.01, 110825.01, 111103.01, 120601-001, 120711.01, 120920.01, 130507.01, 130523.01, 130703.01, 132078, 132084, 132160, 132189, 132190, 132230, 142071, 142286, 142310, 142351, 142352, 142769 and 134 more |
Product
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Reason for recall
Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3251-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.