Z-1385-2018Class II

Intra-Aortic Balloon Catheter Mega 8FR 50cc

Name: Z-1385-2018 Intra-Aortic Balloon Catheter Mega 8FR 50cc
Creator: Datascope Corporation
Published: 2018-02-21
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2018-02-21 / Terminated / root cause: labeling and UDI

FDA source

Datascope Corporation began a recall of Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in... on 2018-02-21. FDA classified it as Class II and gives the reason as "The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1385-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-21
Posted: 2018-04-16
Terminated: 2020-03-18
Recalling firm: Datascope Corp.
Product: Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.
Quantity in commerce: 12744
Distribution: US Nationwide Distribution
Product codes and lots: 0684 00 0296 01U and 0684 00 0296 02U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1385-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1383-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-16
Z-1384-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-16
Z-1385-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-16

Product code DSP

K133074Class IIMega 8Fr. 50Cc and Sensation Plus 8Fr. 50Cc Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp. / cleared 2013-12-12

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)