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U.S. Department of Health and Human Services

Class 2 Device Recall The Sensation Plus 7.5Fr. 40cc IntraAortic Balloon Catheter with accessories

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 Class 2 Device Recall The Sensation Plus 7.5Fr. 40cc IntraAortic Balloon Catheter with accessoriessee related information
Date Initiated by FirmMay 28, 2019
Create DateJuly 12, 2019
Recall Status1 Terminated 3 on September 25, 2023
Recall NumberZ-1966-2019
Recall Event ID 83022
510(K)NumberK122628 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductSensation 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.
Code Information UDI Code: 10607567108063;  Lot Codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information ContactBarb Smith
585-214-6049
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionAn 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 Commerce471
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DSP
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