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 IABP and CARDIOSAVE Rescue IABP affected part number Recalled by Maquet Datascope Corp - Cardiac Assist Division Due to Maquet has received 3 confirmed complaints related to...

Date: December 23, 2016
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 IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

Quantity: 8000

Why Was This Recalled?

Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

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