Home › MEDTRONIC VASCULAR, INC. › Heli-FX™ Thoracic EndoAnchor™ System
Heli-FX™ Thoracic EndoAnchor™ System
MEDTRONIC VASCULAR, INC. · Model HA-18-114 · UDI-DI 00763000645144
1
510(k) clearances
1,181
Adverse events (126 deaths)
1
Recalls
5
Facilities
Description
ACC HA-18-114 TAA APPL-CASS 10 EIFU US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-13 | Medtronic Vascular, Inc. | It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.