Z-1935-2016Class II

MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic...

Name: Z-1935-2016 MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic...
Creator: Datascope Corporation
Published: 2016-05-13
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-05-13 / Terminated / root cause: labeling and UDI

FDA source

Datascope Corporation began a recall of MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA... on 2016-05-13. FDA classified it as Class II and gives the reason as "It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the...". 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-1935-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-13
Posted: 2016-06-08
Terminated: 2019-03-22
Recalling firm: Datascope Corp.
Product: MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 31,030 units (US); 15,604 units (OUS)
Distribution: Worldwide Distribution.
Product codes and lots: (PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1935-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1935-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08

Product code DSP

K120868Class IIMega(tm) 7.5Fr. 30Cc Intra-Aortic Balloon Catheter and Accessories, Mega(tm) 7.5Fr. 40Cc Intra-Aortic Balloon CatheterDatascope Corp., Cardiac Assist Division / cleared 2012-04-20

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)