Insertion Kit for use with SENSATION PLUS 8F. 50cc… recallZ-1687-2022 · Datascope Corporation · initiated Aug 5, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Datascope Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Certain lots containing undersized dilator.

FDA root cause category: Vendor change control

What the company is doing

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 [email protected] or by fax to 877-647-1921.

Recall details

Recall number: Z-1687-2022
Status: Open, Classified
Initiated by the company: Aug 5, 2022
Posted by the FDA: Sep 8, 2022
Recalling firm: Datascope Corporation
Quantity: 10,427 units
Product code: DSP
FDA submissions: K133074
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.

Product description

Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 0884-00-0019-23
Datascope Corp. · System, Balloon, Intra-Aortic And Control
2 recalls2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 90684).

Z-1685-2022 · Open, Classified
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Z-1686-2022 · Open, Classified
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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