Flow diverter devices recalled over tantalum defect affecting vessel wall apposition
MicroVention is recalling 467 FRED and FRED X flow diverters over a manufacturing issue with tantalum length or attachment that may leave the device incompletely open or poorly apposed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states insufficient apposition could lead to long-term health consequences, and no injuries are reported.
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.
- Affected units
- 467
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI(Lot): FRED5019/00811425020388(0000235839)
- 00842429117163(0000544498)
- FRED5029/00811425020395(0000256343)
- 00842429117170(0000507209)
- FRED4528/00811425020425(0000265666)
- FRED4026/00811425021033(0000333125
- 0000576973)
- FRED5526/00842429117194(0000361117)
- FRED4508/00842429117095(0000372088)
- FRED5514/00842429117187(0000429786
- 0000478385)
- FRED3536/00842429117033(0000460268
- 0000445555)
- FRED3511/00842429117002(0000452923)
- FRED5014/00842429117156(0000563591
- 0000464401)
- FRED3516/00842429117019(0000513146
- 0000531733
- 0000536217)
- MV-F451827/04987892121906(0000565094)
Distribution
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