FDA Medical Device Recalls (openFDA)
Maquet Datascope Corp - Cardiac Assist Division: 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.
- Recall number
- Z-1523-2014
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- 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.
- Status
- Terminated
- Initiated
- 2014-03-21
- Posted
- 2014-05-21
- Terminated
- 2018-03-20
- Reason
- 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
- 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
- 11,881 units (US 5183 and OUS 6698)
- Distribution
- Worldwide Distribution - USA (nationwide) and approximately 104 countries.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K031636, K063525, K965236
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3001418283
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28