Datascope recalls YAMATO PLUS IAB catheters due to potential introducer dilator fracture during insertion, risking artery damage or embolization. 10 complaints include 3 serious events and 1 death.
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.
Datascope is recalling YAMATO PLUS IAB catheters and accessories because the introducer dilator can fracture during insertion, potentially causing artery damage or embolization. This risk has led to 10 complaints, including 3 serious adverse events and 1 patient death.
During catheter insertion, the introducer dilator may fracture at the hub, leaving the body inside the sheath. This can damage the femoral artery, descending aorta, or cause embolization. It may also require surgical intervention or delay life-saving therapy.
Healthcare professionals using these catheters for counter-pulsation therapy are most at risk, particularly those with the specific model numbers listed in the recall.
Check for the YAMATO PLUS-R 30cc, 35cc, or 40cc IAB kits with part numbers D684-00-0559-01 through D684-00-0561-02 or UDI numbers 10607567107585 through 10607567107639.
Immediately stop using the recalled YAMATO PLUS IAB catheters and accessories as they pose a risk of serious injury.
The introducer dilator may fracture during insertion, risking damage to the femoral artery, descending aorta, or embolization. This has led to 10 complaints including 3 serious adverse events and 1 patient death.
The affected models include YAMATO PLUS-R 30cc, 35cc, and 40cc IAB kits with specific part numbers and UDI numbers listed in the recall notice.
Check the product label for part numbers D684-00-0559-01 through D684-00-0561-02 or UDI numbers 10607567107585 through 10607567107639.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2216-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2216-2023 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
