Medtronic, Inc. (Minneapolis, MN 55447)
Minneapolis, MN, US
Medtronic, Inc. (Minneapolis, MN 55447) appears in FDA device records in Minneapolis, MN. FDA records list no 510(k) clearances, 60 PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Medtronic, Inc. (Minneapolis, MN 55447) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- ATS Medical, Inc.recall
- Medtronic Ats Medical, Inc.PMA, enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008592544 | 3008592544 | Medtronic, Inc. (Minneapolis, MN 55447) | 3800 ANNAPOLIS LANE, Minneapolis, MN 55447 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0496-2021 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices | Class II | Terminated | |
| Z-0495-2021 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices | Class II | Terminated | |
| Z-0494-2021 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices | Class II | Terminated | |
| Z-0493-2021 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices | Class II | Terminated | |
| Z-1533-2020 | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm | Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral. | Class II | Terminated | |
| Z-0079-2007 | CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console. | Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year. | Terminated | ||
| Z-0634-04 | ATS Open Pivot Mechanical Heart Valve | Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain