medical LOW RISK Updated 2021-06-16

MICROVENTION INC. recalls VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage:

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Recalled Product

VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

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Hazard / Issue

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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