Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2015 - (Recall #: Z-1062-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

Product Classification:

Class II

Date Initiated: December 16, 2014

Date Posted: February 18, 2015

Recall Number: Z-1062-2015

Event ID: 69863

Reason for Recall:

Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.

Status: Terminated

Product Quantity: 838 units-US; 364 units - OUS

Code Information:

Sensation 7 fr.34 cc IAB Demonstration Unit 0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469 Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470 Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units 0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568 Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576 Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated