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 Hybrid IABP Recalled by Maquet Datascope Corp - Cardiac Assist Division Due to There is a potential for interruption and/or inability...

Date: September 20, 2018
Company: Maquet Datascope Corp - Cardiac Assist Division
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 Maquet Datascope Corp - Cardiac Assist Division directly.

Affected Products

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Quantity: N/A

Why Was This Recalled?

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Maquet Datascope Corp - Cardiac Assist Division

Maquet Datascope Corp - Cardiac Assist Division has 14 total recalls tracked by RecallDetector.

Related Recalls

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