Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2018 - (Recall #: Z-0099-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 20, 2018

Date Posted: November 7, 2018

Recall Number: Z-0099-2019

Event ID: 81055

Reason for Recall:

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.

Status: Ongoing

Product Quantity: N/A

Code Information:

UDI - 10607567108391 All Serial Numbers

Distribution Pattern:

US Nationwide; Internationally to 77 countries

Voluntary or Mandated:

Voluntary: Firm initiated