Z-1523-2014Class I

Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump...

Name: Z-1523-2014 Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump...
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2014-03-21
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-03-21 / Terminated / root cause: manufacturing process

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to... on 2014-03-21. FDA classified it as Class I and gives the reason as "Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1523-2014
Classification: Class I
Status: Terminated
Initiated: 2014-03-21
Posted: 2014-05-21
Terminated: 2018-03-20
Recalling firm: Datascope Corp.
Product: Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Maquet Inc. sent an Urgent Medical Device Field Correction letter dated March 21, 2014, to all affected customers. The letter identified the affected product, problem, and actions to be taken.. Customers were instructed that their Service Representatiave would contact them to schedule the replacement of the fan assembly at no cost to the customer. Upon completion customers were requested to sign a service repair order to verify satisfactory completion of the work. Customers with questions within Puerto Rico, were instructed to contact Technical Support in Mexico at +52-55-9000-8970, ext 104. For questions regarding this recall call 973-709-7652. A field correction letter was sent out on April 15, 2014 to additional consignees that did not receive the March 15, 2014 letter. Maquet issued press on May 9, 2014.
Quantity in commerce: 11,881 units (US 5183 and OUS 6698)
Distribution: Worldwide Distribution - USA (nationwide) and approximately 104 countries.
Product codes and lots: IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1523-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1523-2014	Class I	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)