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U.S. Department of Health and Human Services

Class 2 Device Recall Sensation Plus

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  Class 2 Device Recall Sensation Plus see related information
Date Initiated by Firm August 05, 2022
Date Posted September 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-1687-2022
Recall Event ID 90684
510(K)Number K133074  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Code Information Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108599, 3000170709, 0884-00-0019-23; 10607567108599, 3000182611, 0884-00-0019-23; 10607567108599, 3000202083, 0884-00-0019-23
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact Datascope Corp./Getinge Customer Support
1-888-943-8872 Ext. 2
Manufacturer Reason
for Recall		 Certain lots containing undersized dilator.
FDA Determined
Cause 2		 Vendor change control
Action The firm distributed an Urgent Medical Device Removal notification, by mail, dated August 5, 2022. The notification informs customers that certain lots of 8Fr. 50cc IAB catheter and insertion kits are being recalled due to an undersized vessel dilator. During a sheathless insertion, the undersized inner diameter may result in the inability to insert the guidewire through the inner lumen of the dilator and the undersized outer diameter may reduce dilation of the vessel. If used in a procedure, recalled product could result in a procedural delay, gas emoli, and vessel injury. Customers are asked to examine their inventory to determine if they have nay recalled product and to quarantine any affected units. Customers with recalled product are to contact Datascope Corp./Getinge Customer Service at 888-9GETUSA (888-943-8872, option 2) between the hours of 8 AM and 6 PM to request a return authorization number to receive full credit. Distributors who have shipped any product are to forward the notification to customers. The recall notification is to be forwarded to all users at hospitals/facilities. Customers are asked to complete and return the recall response form by email to Dilator8Fr2022@getinge.com or by fax to 877-647-1921.
Quantity in Commerce 10,427 units
Distribution Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
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