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Evolution
COOK IRELAND LTD · Model G48038 · UDI-DI 10827002480381
MQR
Prescription
10
510(k) clearances
1,327
Adverse events (106 deaths)
2
Recalls
13
Facilities
Description
EVOLUTION COLONIC, STENT SYSTEM - UNCOVERED
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life |
| 2010-07-15 | Boston Scientific Corporation | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
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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.