Z-1966-2019Class II

Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01

Name: Z-1966-2019 Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01
Creator: Datascope Corporation
Published: 2019-05-28
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2019-05-28 / Terminated / root cause: manufacturing process

FDA source

Datascope Corporation began a recall of Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc... on 2019-05-28. FDA classified it as Class II and gives the reason as "The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1966-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2019-07-12
Terminated: 2023-09-25
Recalling firm: Datascope Corp.
Product: Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation 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 device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An Urgent Medical Device Recall notification letters dated 5/28/19 was sent to the customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached URGENT MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM on page 3, to acknowledge that you have received the Sensation Plus 7.5 Fr. 40cc Intra-Aortic Balloon Catheter with Accessories URGENT MEDICAL DEVICE RECALL. Please fax or email the completed Customer Response Form to 1-585-486-5605.
Quantity in commerce: 471
Distribution: The products were distributed to the following US states: FL. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, Ukraine.
Product codes and lots: UDI Code: 10607567108063; Lot Codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1966-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1966-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code DSP

K122628Class IISensation Plus 7.5Fr. 40Cc Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division / cleared 2012-09-06

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)