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Flo-Thru Intraluminal Shunt® FT-12250Recalls & reported problems

Synovis Life Technologies, Inc. · The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K981624); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 22, 2024Open, Classified

    The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).

    Z-1522-2024 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981624. One submission often covers many models, so check the product and lot details in each record.

  • Z-1523-2024 · Feb 22, 2024 · Open, Classified
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-A
  • Z-0663-2024 · Dec 6, 2023 · Open, Classified
    Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product
  • Z-1019-2022 · Apr 1, 2022 · Terminated
    Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for

Other CLAMP, VASCULAR devices

All CLAMP, VASCULAR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.