Datascope recalls reinforced introducer sets for IAB catheter use due to fracture risk during insertion, potentially causing arterial damage or embolization. 10 complaints including 3 serious events and 1 death reported.
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 reinforced introducer sets used with intra-aortic balloon catheters because the introducer dilator can fracture during insertion, risking arterial damage or embolization. This could lead to serious complications requiring surgery or delaying life-saving treatment.
During catheter insertion, the introducer dilator may break at the hub, leaving part of the device inside the catheter sheath. This can damage blood vessels like the femoral artery or aorta, cause embolism, or require emergency surgery.
Healthcare professionals using these devices for counterpulsation therapy in the aorta are most at risk. Patients receiving this treatment could face severe complications if the device fractures.
Check for part numbers D684-00-0403-05, D684-00-0403-06, or D684-00-0403-10 on the product packaging. These sets were sold for use with specific catheter systems like Linear 7.5Fr and MEGA 7.5Fr.
Immediately stop using the recalled reinforced introducer sets as they can fracture during insertion, causing serious injury.
Recalled part numbers are D684-00-0403-05, D684-00-0403-06, and D684-00-0403-10.
The manufacturer has received 10 complaints, 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-2224-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2224-2023 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.
