The Recall Desk
HighFDA (Devices)·Z-0108-2026·Announced 2025-10-22

[pending] Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED552

Pending LLM rewrite. Source: FDA_DEVICE Z-0108-2026.

What this means for you

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: Pending LLM scoring against the rubric.

Plain-English summary

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

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 — Devices

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

Distributed nationwide across the United States.

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