Medtronic CryoConsole — Class II medical device recall Z-2777-2015
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2015-09-23, distributed nationwide. An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedur
| Recall number | Z-2777-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2015-09-01 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2016-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, DE, DZ, ES, FR, GB, GR, IE, IL, IS, IT, LB, MY, NL, PL, RO, SE, SI, TR, TW, ZA |
| Quantity | 103 units |
| Serial numbers | 5K0005, 5K0006, 5K0007, 5K0009, 5K0010, 5K0011, 5K0012, 5K0013, 5K0014, 5K0015, 5K0016, 5K0017, 5K0018, 5K0019, 5K0020, 5K0021, 5K0022, 5K0023, 5K0024, 5K0025, 5K0026, 5K0027, 5K0028, 5K0029, 5K0030 and 113 more |
| Model numbers | 106A2-K, 106A3, 106E2 |
Product
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Reason for recall
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
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-2777-2015. 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.