Question 1

What product was recalled?

Accepted Answer

LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES	D684-00-0479-01  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)	D684-00-0479-02  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA)	D684-00-0479-01C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA)	D684-00-0479-02C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA)	D684-00-0479-07  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA)	D684-00-0479-08  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY)	D684-00-0479-09  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY)	D684-00-0479-10  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY	D684-00-0479-01U  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY	D684-00-0479-02U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES	D684-00-0480-01  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)	D684-00-0480-02  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)	D684-00-0480-01C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA)	D684-00-0480-02C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA)	D684-00-0480-07  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA)	D684-00-0480-08  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)	D684-00-0480-09  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY)	D684-00-0480-10  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY	D684-00-0480-01U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY	D684-00-0480-02U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES	D684-00-0478-01  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA)	D684-00-0478-02  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA)	D684-00-0478-01C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA)	D684-00-0478-02C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA)	D684-00-0478-07  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA)	D684-00-0478-08  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY)	D684-00-0478-09  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY)	D684-00-0478-10  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY	D684-00-0478-01U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY	D684-00-0478-02U  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs 	D884-00-0019-12  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs	D884-00-0019-13. Recalled by Datascope Corp.. Units affected: 321,609 total kits.

Question 2

Why was this product recalled?

Accepted Answer

During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

Question 3

Which agency issued this recall?

Accepted Answer

This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2223-2023.

Product Description

Reason for Recall

Details

Frequently Asked Questions

Related Recalls

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Explore Related Data