Datascope recalls LINEAR 7.5Fr 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 LINEAR 7.5Fr IAB catheters and accessories because the introducer dilator may fracture during insertion, potentially causing artery damage or embolization. This could lead to surgery or delays in critical counterpulsation therapy.
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 life-saving therapy or require surgery.
Healthcare professionals using these catheters for aortic counterpulsation therapy are affected. Patients receiving this treatment are at risk of serious injury or death if the catheter fractures during insertion.
Check for the product names: LINEAR 7.5Fr IAB with accessories. Look for part numbers like D684-00-0479-01 or D884-00-0019-12. These were sold in the US, India, China, and Turkey with specific regional variants.
Immediately stop using the recalled LINEAR 7.5Fr IAB catheters and accessories if you have them.
The introducer dilator may fracture during insertion, risking damage to blood vessels like the femoral artery or descending aorta, or causing embolization.
The recall includes multiple variants sold in the US, India, China, and Turkey with specific part numbers listed in the product details.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2223-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2223-2023 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.
