Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Recalled by Datascope Corp. Due to Users were identifying autofill failure conditions on the...

Date: July 31, 2023
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 Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Quantity: 9175 units

Why Was This Recalled?

Users were identifying autofill failure conditions on the devices causing pump stops.

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