Datascope recalls SENSATION PLUS 7.5Fr IAB catheters due to risk of introducer dilator fracturing during insertion, potentially causing arterial 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 SENSATION PLUS 7.5Fr IAB catheters because the introducer dilator may fracture during insertion, risking arterial damage or embolization. This could lead to surgery or delayed treatment. The recall includes specific model numbers and accessories.
During catheter insertion, the introducer dilator can fracture at the hub, leaving part of it inside the sheath. This may damage blood vessels like the femoral artery or descending aorta, or cause embolization. It can also delay critical treatment and require surgery.
Healthcare professionals using the catheter for counterpulsation therapy are affected. Patients receiving this treatment are at highest risk due to potential arterial damage or embolization.
Check for model numbers D684-00-0568-01, D684-00-0568-03, D684-00-0568-05, D684-00-0568-09, or D684-00-0568-01U on the packaging. The product was sold for counterpulsation therapy in the aorta.
Immediately stop using the recalled catheter as it can fracture during insertion, causing serious injury.
The recalled models include D684-00-0568-01, D684-00-0568-03, D684-00-0568-05, D684-00-0568-09, and D684-00-0568-01U.
10 complaints have been reported, including 3 serious adverse events and 1 patient death.
The recall record does not mention a remedy or replacement option.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2221-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2221-2023 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.
