Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products Recalled by Arrow International Inc Due to Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer...

Date: April 14, 2014
Company: Arrow International Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.

Affected Products

Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.

Quantity: 15424

Why Was This Recalled?

Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Arrow International Inc

Arrow International Inc has 431 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report