Z-2568-2014Class III

LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

Name: Z-2568-2014 LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Creator: Datascope Corporation
Published: 2014-08-11
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-08-11 / Terminated / root cause: labeling and UDI

FDA source

Datascope Corporation began a recall of LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group on 2014-08-11. FDA classified it as Class III and gives the reason as "During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter". 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-2568-2014
Classification: Class III
Status: Terminated
Initiated: 2014-08-11
Posted: 2014-09-03
Terminated: 2015-02-05
Recalling firm: Datascope Corp.
Product: LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).
Quantity in commerce: one unit
Distribution: US Distribution to TX.
Product codes and lots: Part Number - 0684-00-0480-01U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2568-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2568-2014	Class III	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-03

Product code DSP

K041281Class IIDatascope 7.5Fr. Iab Catheter and AccessoriesDatascope Corp. / cleared 2004-06-07

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)