Reported Aug 2, 2023 · Ongoing
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.…
Datascope Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datascope Corp. · 15 Law Dr Unit 1 · Fairfield, NJ · 07004-3206
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
D684-00-0559-01 | 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 |
D684-00-0559-02 | YAMATO PLUS-R 30cc 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 35cc IAB WITH ACCESSORIES AND RETRACTION KIT |
D684-00-0561-01 | YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT |
D684-00-0561-02 | YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT |
D886-00-0019-25 | PACKAGED INSERTION KIT - YAMATO PLUS-R 7.5 Fr. 30/35/40 cc IABs |
- Lot codes and dates
- 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
- Amount recalled
- 321,609 total kits
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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