Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion
The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall involves a reported patient death. Per the severity rubric, any documented death results in a Critical (5) rating regardless of other factors. This device failure during insertion creates risk of major vascular injury, blood clots, and surgical emergency.
Plain-English summary
The FDA has issued a recall of Datascope Corp.'s YAMATO PLUS intra-aortic balloon (IAB) catheter kits. These devices are used to provide counter-pulsation therapy in the aorta to support cardiac function.
During insertion, the introducer dilator—a component used to guide the catheter into the vessel—may fracture at the hub. This can leave the fractured body of the dilator inside the sheath, creating serious risks.
Potential complications include damage to the femoral artery, damage to the descending aorta, or embolization (blood clot formation). Patients may require emergency surgical intervention, and the fracture may delay necessary IAB therapy. Datascope has received 10 complaints about this defect, including 3 serious adverse events and 1 patient death.
Healthcare facilities and clinicians using these kits should take appropriate action. Contact Datascope or consult the FDA website for guidance on device disposition, inspection protocols, or replacement options.
The recalled product
- 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…
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiovascular
- Affected units
- 321,609
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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