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

FRED Flow Diverter Devices Recalled for Manufacturing Defect Risk

MICROVENTION is recalling specific FRED 27 and FRED X 27 flow diverter devices due to a manufacturing issue affecting tantalum length or attachment pattern. The defect may prevent proper device positioning in blood vessels, potentially requiring device recapture.

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: This is a Class II FDA medical device recall with no reported illnesses, injuries, or deaths. The manufacturing defect represents a theoretical risk of improper device positioning during a surgical procedure. Per FDA rubric guidance, recalls with documented hazards but no evidence of actual patient harm are rated at most 3.

Plain-English summary

MICROVENTION INC. is recalling 467 FRED 27 and FRED X 27 flow diverter endoluminal devices distributed worldwide. These devices are used in vascular procedures to redirect blood flow away from affected vessels.

The recall was initiated due to a manufacturing issue related to tantalum length and/or tantalum attachment pattern in affected units. This defect may cause the device to be incompletely open or not properly positioned against the vessel wall during implantation.

If the device does not properly appose to the vessel wall, it may necessitate recapture and withdrawal of the delivery system and microcatheter together. Insufficient positioning could lead to long-term health consequences. Affected lot numbers and UDI codes are provided on the FDA website.

Healthcare providers who have used or implanted these devices should review the specific lot numbers and contact MICROVENTION regarding their inventory. Patients who have received these devices should consult with their physicians.

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 — Vascular / Flow Diverter
Hazard
  • manufacturing-defect
  • device-malposition
  • incomplete-deployment

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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