Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Cardiosave Rescue IABP - Product Usage: used to inflate and Recalled by Datascope Corp. Due to There are cybersecurity vulnerabilities in a widely used...

Date: March 22, 2021
Company: Datascope Corp.
Status: Ongoing
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 Datascope Corp. directly.

Affected Products

Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Quantity: 10087 total

Why Was This Recalled?

There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Datascope Corp.

Datascope Corp. has 66 total recalls tracked by RecallDetector.

Related Recalls

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