Technology | June 15, 2011

Maquet Datascope Recalls Intra-Aortic Balloon Pumps

Maquet Datascope CS300 Intra-Aortic Balloon Pump

Maquet Datascope CS300 Intra-Aortic Balloon Pump

 

June 15, 2011 – The U.S. Food and Drug Administration (FDA) said Maquet Datascope Corp. has issued a class I recall for its System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) because of a defective fan in the power supply. The defect may cause overheating and shut down the device without visible or audible alarms. The company said consequences of unanticipated interruption of therapy could include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

The recall includes 885 devices manufactured between May 2008 and December 2010. Affected lot/serial numbers include 7081436, 7081963, 7083463, and 7090616.

Affected models include:

  • 0998-00-0446-xx
  • 0998-UC-0446-xx
  • 0998-00-0479-xx
  • 0998-UC-0479-xx
  • 0998-UC-0446Hxx
  • 0998-UC-0479Hxx
  • 0998-00-3013-xx
  • 0998-UC-3013-xx
  • 0998-00-3023-xx
  • 0998-UC-3023-xx

 

IABPs are an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart during cardiac surgery or interventional cath lab procedures.

Maquet Datascope notified customers by letter on March 17 describing the problem, the potential hazard, and the action to be taken. Customers were advised that their service representative would arrange to replace the power supply on affected devices, which would contain a new fan assembly.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The Maquet Technical Support Department can be reached at 800.777.4222 and press 4 (Monday through Friday 9 a.m. to 5:30 p.m. EST).

For more information: www.fda.gov/Safety/MedWatch/default.htm

Related Content

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump
News | Intra-Aortic Balloon Pumps (IABP) | September 24, 2018
September 24, 2018 — Getinge is voluntarily initiating a worldwide recall involving a field correction of approximate
Maquet Datascope Corp. is recalling the CardioSave Hybrid Intra-aortic Balloon Pump (IABP).

The touchscreen Maquet Datascope CardioSave Hybrid Intra-aortic Balloon Pump (IABP) system console.

News | Intra-Aortic Balloon Pumps (IABP) | June 06, 2018
June 6, 2018 — Maquet Datascope Corp.
An example of an intra-aortic balloon pump (IABP) from Maquet. The results of the SEMPER FI trial. #europcr2018 #Europcr

An example of an intra-aortic balloon pump (IABP) from Maquet. 

Feature | Intra-Aortic Balloon Pumps (IABP) | May 31, 2018
May 31, 2018 — The results from the Survival Improvement in Extensive Myocardial Infarction with PERsistent Ischemia
FDA Clears Teleflex Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP)
Technology | Intra-Aortic Balloon Pumps (IABP) | May 02, 2017
May 2, 2017 — The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the Teleflex Inc.
Impella CP heart pump, TCT 2016, intra-aortic balloon counterpulsation, IABP, clinical study
News | Intra-Aortic Balloon Pumps (IABP) | January 03, 2017 | Dave Fornell
The Impella CP heart pump (Abiomed) demonstrated no improvement in mortality for patients with myocardial infarction...
Teleflex, Arrow IAB catheter, intra-aortic balloon pump, worldwide recall
News | Intra-Aortic Balloon Pumps (IABP) | March 11, 2016
Teleflex Inc. announced the worldwide recall of Arrow International intra-aortic balloon catheter kits and percutaneous...
Overlay Init