Events

Recall of Device Recall System 98/98XT, CS100/CS100i, CS300 IntraAortic Balloon Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Datascope Corp - Cardiac Assist Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58661
  • Event Risk Class
    Class 1
  • Event Number
    Z-2414-2011
  • Event Initiated Date
    2011-03-16
  • Event Date Posted
    2011-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99835
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Intra-Aortic Balloon Pump - Product Code FMZ
  • Reason
    Several models of the intra-aortic balloon pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.
  • Action
    Maquet sent an Urgent Product Field Correction letter dated March 16, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to note the WARNING in the IABP Operating Instruction. Customers were advised to refer to the IAB Instructions for Use, Section D (Manually inflating and Deflating a Catheter). Section D of the IAB instruction for Use reiterates that an IAB should not remain inactive for more than 30 minutes and also provides detailed instruction on how to keep an IAB active during IABP failure. Customers were advised that their Service Representatiave would arrange to replace their supply which would contain a new fan assembly. Upon completion of the power supply replacement, customers were asked to sign a service repair order to verify satisfactory completion of the work. For technical questions contact Technical Support Department at 1-800-777-4222 and press 4. For scheduling a service visit by a Field Service Representatiave, contact the firm's US Call Center at 1-800-777-4222 and press 3. Maquet issued a press release on June 6, 2011 advising consumers of the issue and that their recall was considered a class one.

Device

Device Recall System 98/98XT, CS100/CS100i, CS300 IntraAortic Balloon Pump
  • Model / Serial
    System 98 - Part Numbers 0998-00-0446-xx, 0998-UC-0446-xx;  System 98XT - Part numbers 0998-00-0479-xx, 0998-UC-0479-xx ;  CS100i- Part numbers 0998-UC-0446Hxx, 0998-UC-0479Hxx;  CS100 - Part numbers 0998-00-3013-xx, 0998-UC-3013-xx;  CS300 - Part numbers 0998-00-3023-xx, 0998-UC-3023-xx
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; || Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 || The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • Manufacturer Address
    Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA