Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2016 - (Recall #: Z-1248-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Cardiosave Hybrid and rescue IABP

Product Classification:

Class II

Date Initiated: December 16, 2015

Date Posted: April 6, 2016

Recall Number: Z-1248-2016

Event ID: 72890

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1243 units US; 1107 units OUS

Code Information:

Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

Distribution Pattern:

Worldwide Distribution- Nationwide Distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated