Z-1928-2018Class I

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding...

Name: Z-1928-2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding...
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2018-05-03
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2018-05-03 / Open, Classified / root cause: design

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 &... on 2018-05-03. FDA classified it as Class I and gives the reason as "Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1928-2018
Classification: Class I
Status: Open, Classified
Initiated: 2018-05-03
Posted: 2018-05-31
Recalling firm: Datascope Corp.
Product: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Root cause tag: design
FDA root cause: Device Design
Action: Notification of the field correction was posted to the firm's website on 5/3/18 at https://www.maquet.com/globalassets/downloads/product-articles/cardiosave/ml_0730_us_rev_a_cardiosave_fluid_ingress_recall_customer_letter_us_4may2018.pdf. Mailed notification letters will be issued to customers as well. The instructions included in the notification includes the following: Patients receiving IABP therapy are in critical condition. Failure to start or sudden interruption of therapy could result in unsafe, hemodynamic instability. Until the protective top cover is installed, please adhere to the following instructions when using Cardiosave intra-aortic balloon pump: 1) Pursuant to the Caution section of our Cardiosave IABP Operating/User Instructions, Never place fluids on top of this unit. Make sure that the saline container and tubing do not hang directly over the IABP. In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists In the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. The Intra-Aortic Balloon (IAB) Catheter Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate, repeat every 5 minutes until either an alternate IABP is available or alternatively, the intra-aortic balloon catheter should be removed from the patient. Please refer to the intra-aortic balloon catheter instructions for use, Manually Inflating and Deflating a Catheter. The patient should be treated according to your facilitys treatment protocols and caregivers clinical judgment to ensure hemodynamic stability. Affected customers will be contacted by a Maquet/Getinge representative to schedule on-site service of your Cardiosave IABP by a Maquet/ Getinge Sales or Service Re
Quantity in commerce: 4300
Distribution: The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam. The devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.
Product codes and lots: All Serial Numbers distributed from 03/06/2012 to 04/26/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1928-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2018	Class I	Ongoing	Voluntary: Firm initiated	2018-06-06	2018-05-31

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)