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PROMUS Element™ Plus
BOSTON SCIENTIFIC CORPORATION · Model H7493911620400 · UDI-DI 08714729807698
NIQ
Prescription
0
510(k) clearances
128,928
Adverse events (11,243 deaths)
6
Recalls
31
Facilities
Description
Everolimus-Eluting Platinum Chromium Coronary Stent System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-25 | Abbott Vascular | Incorrect expiration date |
| 2013-10-07 | Medtronic Vascular, Inc. | A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm |
| 2009-08-06 | Medtronic Vascular Galway Limited | The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and Instructions For Use. |
| 2005-01-12 | Cordis Corporation | Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met. |
| 2004-11-18 | Cordis Corporation | Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004. |
| 2004-07-01 | Boston Scientific Scimed | On a few occasions the balloon has failed to deflate within one minute after deployment of the stent. |
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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.