Z-1386-2017Class II

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery...

Name: Z-1386-2017 CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery...
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2016-12-23
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-12-23 / Terminated / root cause: design

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage... on 2016-12-23. FDA classified it as Class II and gives the reason as "Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1386-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-03-02
Terminated: 2019-03-01
Recalling firm: Datascope Corp.
Product: CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to [email protected]
Quantity in commerce: 8000
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: part number 0146-00-0097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1386-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1386-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-03-01

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)