Flow diverter devices recalled over tantalum defect affecting vessel wall apposition

Plain-English summary

Flow Re-Direction Endoluminal Devices, covering FRED 27 and FRED X 27 across a range of reference numbers, are being recalled.

The flow diverter may have a manufacturing issue related to the tantalum length and/or the tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall. That may necessitate device recapture and withdrawal of the delivery system and microcatheter together. The firm states that insufficient apposition could lead to long-term health consequences.

The recall covers 467 units, distributed worldwide including in South Dakota, California, South Carolina, Texas, Florida, Colorado, Nebraska and New York. The FDA has classified the action as Class II.

The enforcement record describes the deployment issue and reports no injuries. Facilities should identify affected reference and lot numbers and follow MicroVention's instructions.

The recalled product

Product

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,

Manufacturer

MICROVENTION INC.

Category

Medical Device — Neurovascular implant

Hazard

• manufacturing-defect
• device-apposition
• deployment-failure
• implant

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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