Class II — Potential Health Hazard

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

CryoPatch SG Pulmonary Hemi-Artery Recalled by CryoLife, Inc. Due to The conduit length and branch length of a...

Date: September 6, 2018
Company: CryoLife, 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 CryoLife, Inc. directly.

Affected Products

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

Quantity: 1 graft

Why Was This Recalled?

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CryoLife, Inc.

CryoLife, Inc. has 14 total recalls tracked by RecallDetector.

Related Recalls

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