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High RiskFDAfda-Z-0114-2017OTHER

VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interve...

Units Affected
618
Recall Date
September 23, 2016
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0114-2017.

Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0114-2017.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Sequent Medical Inc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0114-2017.

Sequent Medical Inc

FDA

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Sequent Medical Inc Recall FAQ

Sequent Medical Inc is the subject of a medical implants safety report: VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interve.... The notice was published on September 23, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 618 units are potentially affected.