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

FDA device recall Z-1687-2022 · posted 2022-09-08 · Open, Classified

Recall details

Recalling firm

Datascope Corporation

Reason for recall

Certain lots containing undersized dilator.

Action taken

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.

Root cause

Vendor change control

Status

Open, Classified

Product code

DSP

Quantity affected

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 Arab

Date initiated

2022-08-05

Date posted

2022-09-08

Location

Fairfield, NJ

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