YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-01 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-02 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-01 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-02 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0561-01 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0561-02 PACKAGED INSERTION KIT - YAMATO PLUS-R 7.5 Fr. 30/35/40 cc IABs D886-00-0019-25
This recall is currently active, issued July 21, 2023. It was issued by Datascope Corp..
- Company
- Datascope Corp.
- Recall Initiated
- June 23, 2023
- Posted
- July 21, 2023
- Recall Number
- Z-2216-2023
- Quantity
- 321,609 total kits
- Firm Location
- Fairfield, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Domestic distribution nationwide. International distribution worldwide.
Lot / Code Info
Product Description UDI YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107585 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107592 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107608 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107615 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107622 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107639
Root Cause
Under Investigation by firm
Action Taken
Firm notified customers on June 23, 2023 via letter. Customers were made aware of the potential for the device to break during use and the risk of using the device. Customers were given alternate solutions to continue using the IAB Catheter with alternative sheath/dilator combinations. Customers may also return their affected product for a credit. The firm will continue to ship product to customers who choose to continue receiving it. However, product currently being shipped is potentially affected by the same issue. Datascope/Getinge has identified the issue with the introducer dilator and is working with the supplier towards a resolution. If you have any questions, please contact your Datascope/Getinge representative or call Datascope/Getinge Customer Service at 1-888-943-8872, options 2, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).