CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION

FDA device recall Z-1062-2015 · posted 2015-02-07 · Terminated

Recall details

Recalling firm

Maquet Datascope Corp - Cardiac Assist Division

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.

Action taken

Maquet Inc. sent a Product Recall Medical Device Field Correction letter/Field Correction response form, dated 12/16/2014 via Fed Ex. The letter identified the affected product and the reason for the recall. Users were asked to inspect their inventory for the affected units. If customers have any affected product, they are to follow the instructions provided. Additionally, users are to complete and return the attached Field Correction Response Form to acknowledge receipt of the letter and to indicate completion of the steps outlined. Completed forms should be returned by e-mailing a scanned copy to fieldactions@maquet.com or faxing a copy to 1-973-396-3607. Technical questions should be directed to the Technical Support Department at 1-800-777-4222.

Root cause

Device Design

Status

Terminated

Product code

DSP

Quantity affected

838 units-US; 364 units - OUS

Distribution

Worldwide Distribution

Date initiated

2014-12-16

Date posted

2015-02-07

Date terminated

2017-06-09

Location

Mahwah, NJ

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