Medtronic FDA records and Canada–US comparison
This is what a paid workspace shows for every company you track. Records are matched by cleaned company name and are possible matches; each one links to the original FDA or Health Canada record. A missing record is "No apparent match", never proof a device is unlicensed.
Canada–US comparison
| Measure | US FDA | Health Canada |
|---|---|---|
| Registered company records | 3 | 3 |
| Recalls on file | 157 | 36 |
| Clearances / approvals | 6700 | Not tracked here |
Latest FDA recalls
2026-05-06 · Class II · Z-1948-2026
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Regulator record2026-01-21 · Class II · Z-1098-2026
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Regulator record2025-12-10 · Class II · Z-0726-2026
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Regulator record2025-07-30 · Class II · Z-2169-2025
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
Regulator record2025-07-30 · Class II · Z-2168-2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
Regulator record
Latest Health Canada recalls
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Vanta/Sequentia Lt Clinician Programmer Application
Regulator record—
Deep Brain Stimulation Clinician and Patient Programmer Applications
Regulator record—
Vanta Clinician Programmer Application
Regulator record—
DLP Vessel Cannulae
Regulator record—
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (2021-03-05)
Regulator record
Recent FDA clearances and approvals
2026-10-16 · PMA · P860004
SynchroMed Infusion System, Ascenda Intrathecal Catheters
Regulator record2026-10-09 · PMA · P240013
Affera Sphere-9 Mapping and Ablation Catheter
Regulator record2026-10-06 · PMA · P960009
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Regulator record2026-10-06 · PMA · P240013
Sphere-9 Catheter and Affera Ablation System
Regulator record2026-10-05 · PMA · P980035
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG
Regulator record2026-10-05 · PMA · P010015
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P
Regulator record2026-10-02 · PMA · P240013
Sphere-9 Catheter and Affera Ablation System
Regulator record2026-09-30 · PMA · P200046
Harmony TPV System
Regulator record
What the paid plan adds
- The same view for your company, competitors and suppliers — full history, not just the latest five.
- Alerts when a new recall, warning letter or clearance appears in either country.
- Cross-border matches with confidence scores, plus EU, UK, adverse-event and trial data.
- Weekly competitor emails, exports and shareable reports.