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CERENOVUS ENTERPRISE

Medos International Sàrl · Model ENF402312 · UDI-DI 10886704075356

NJE Prescription

510(k) clearances

7,916

Adverse events (537 deaths)

Recalls

Facilities

Description

CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 23 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 2.0 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.

Recalls

Date	Firm	Reason
2018-06-05	Stryker Neurovascular	Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
2014-10-22	Stryker Neurovascular	Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
2013-06-24	Stryker Neurovascular	The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Mode
2011-03-21	Codman & Shurtleff, Inc.	Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.
2010-08-25	Boston Scientific Corporation	Products may not meet radial force specifications.
2010-03-01	Boston Scientific Corporation	The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the requ
2009-05-08	Boston Scientific Corporation	Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton.

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Data 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.