Recall record at a glance
| Official record | Z-2777-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Report date | Sep 23, 2015 |
| Recall initiation date | Sep 1, 2015 |
| Quantity | 103 units |
| Location | Saint Paul, MN, United States |
Official product description
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Why the product was recalled
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
Distribution information
Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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