Datascope recalls MEGA 8Fr 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 its MEGA 8Fr IAB catheters 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 broken piece inside the sheath. This can damage the femoral artery, descending aorta, or cause embolization. It may also require surgery or delay life-saving therapy.
Patients receiving this catheter for counterpulsation therapy in the aorta. Those with the specific model numbers listed in the recall are most at risk.
Check for the product names and part numbers listed in the recall: MEGA 8Fr 50cc IAB with STATLOCK, or accessories variants. The product was sold with specific country labels (US, Turkey, China, India).
Immediately stop using the recalled catheter and accessories if you have them. Contact Datascope for a replacement or return.
The introducer dilator may fracture during insertion, risking damage to the femoral artery, descending aorta, or embolization. This has caused 10 complaints including 3 serious events and 1 death.
MEGA 8Fr 50cc IAB with STATLOCK (D684-00-0296-01), with STATLOCK & APA (D684-00-0296-02), and accessories variants with specific country labels.
Look for the part numbers listed in the recall: D684-00-0296-01 to D684-00-0498-08 or the UDI codes 10607567108001 to 10607567109763.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2220-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2220-2023 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.
