Z-1279-2023Class II

Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

Name: Z-1279-2023 Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Creator: Datascope Corp.
Published: 2023-02-28
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2023-02-28 / Open, Classified

FDA source

Datascope Corp. began a recall of Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178 on 2023-02-28. FDA classified it as Class II and gives the reason as "There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1279-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-28
Posted: 2023-03-22
Recalling firm: Datascope Corp.
Product: Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION dated 2/28/23 was sent to customers. User Actions to be taken: A review of our records indicate that you may have a Cardiosave IABP at your facility with an affected Safety Disk or affected spare Safety Disks or PIM assembly installed recently into Cardiosave IABP. 1. Please examine your inventory immediately to determine if you have any Cardiosave IABPs with the affected Safety Disks and/or PIM, or any affected Safety Disk and/or PIM assembly spare parts, per attachment 1. 2. You may continue to use any affected IABPs until replacement parts are installed. Please keep in mind the potential health risks cited above, particularly with prolonged heart rates above 100 beats per minute for three consecutive hours. When transporting patients outside the hospital environment, consider using an unaffected console if available. 3. Should you have any unused affected spare parts of the Safety Disk or PIM Assembly in your inventory, please remove them from areas of use and contact your local Datascope/Getinge Customer Service department at 888-9GETUSA (888 943-8872) to request a return authorization (RMA) and shipping instruction to return the affected product for credit. 4. If you installed an affected spare part into one of your IABPs the Safety Disk will need to be replaced. 5. If you purchased spare parts and they are no longer in your inventory and you are unsure of their location, please contact Getinge Service. Getinge Service will schedule an on-site visit to inspect your IABP/(s) at no cost to your facility. 6. Should you have any affected Cardiosave IABPs you will be contacted by a Getinge Service Representative to schedule an on-site visit to replace the Safety Disk, free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone
Quantity in commerce: 10
Distribution: Distribution list not yet provided.
Product codes and lots: Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1279-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-22
Z-1277-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-22
Z-1278-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-22
Z-1279-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-22

Product code DSP

K112372Class IICardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC / cleared 2011-09-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)