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APTUS Heli-FX®
MEDTRONIC, INC. · Model SA-85 · UDI-DI 00643169647695
1
510(k) clearances
1,193
Adverse events (126 deaths)
1
Recalls
5
Facilities
Description
ACC SA-85 AAA APPLIER-CASSETTE 10 MDT
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. |
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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.