medical MODERATE Updated 2023-08-02

Datascope Corp. recalls YAMATO PLUS IAB; intra-aortic balloon catheter and accessori

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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