Datascope recalls SENSATION PLUS 8Fr IAB catheters due to risk of introducer dilator fracturing during insertion, potentially causing 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 SENSATION PLUS 8Fr IAB catheters because the introducer dilator can fracture during insertion, risking damage to major arteries or causing life-threatening embolisms. This recall follows 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 (blood clots traveling to vital organs). It may also require emergency surgery or delay critical treatment.
Healthcare professionals using the catheter for counterpulsation therapy are most at risk. Patients receiving this treatment could face severe complications if the catheter fractures during insertion.
The product is labeled 'SENSATION PLUS 8Fr. IAB' with part numbers D684-00-0576-01 to D684-00-0576-09 or 10607567108605 to 106607567109633. It was sold for counterpulsation therapy in the aorta.
Discontinue use of the SENSATION PLUS 8Fr IAB catheter if it is part of the recalled series.
The introducer dilator may fracture during insertion, risking damage to major arteries or causing embolization. This has led to 10 complaints, including 3 serious adverse events and 1 patient death.
Part numbers D684-00-0576-01 to D684-00-0576-09 and UDI codes 10607567108605 to 10607567109633.
The recall does not specify a fix; the remedy is null, meaning users must stop using the product immediately.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2222-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2222-2023 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.
