Class II — Potential Health Hazard

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

Cardiosave Hybrid and rescue IABP Recalled by Maquet Datascope Corp - Cardiac Assist Division Due to Maquet has recieved information that in some Cardiosave...

Date: December 16, 2015
Company: Maquet Datascope Corp - Cardiac Assist Division
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 Maquet Datascope Corp - Cardiac Assist Division directly.

Affected Products

Cardiosave Hybrid and rescue IABP

Quantity: 1243 units US; 1107 units OUS

Why Was This Recalled?

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

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