Datascope recalls SENSATION 7 Fr. IAB catheters due to potential introducer dilator fracture during insertion, risking artery 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 SENSATION 7 Fr. IAB catheters because the introducer dilator may fracture during insertion, potentially causing artery damage, embolization, or requiring surgery. This recall follows 10 complaints including 3 serious adverse events and 1 patient death.
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, cause embolization, or require emergency surgery.
Patients receiving counterpulsation therapy using the recalled catheters are affected. Those with the specific model numbers listed in the recall are most at risk.
Check for the product names: SENSATION 7 Fr. 34cc or 40cc IAB with accessories. Look for model numbers like D684-00-0469-01U (US) or D684-00-0469-01 (standard) on packaging or labels.
Discontinue use of the recalled SENSATION 7 Fr. IAB catheter if you have it.
SENSATION 7 Fr. 34cc and 40cc IAB catheters with accessories, including specific model numbers like D684-00-0469-01U (US) or D684-00-0469-01 (standard).
The introducer dilator may fracture during insertion, risking damage to blood vessels, embolization, or requiring emergency surgery. 10 complaints including 3 serious events and 1 death were reported.
The recall does not provide a remedy; users must stop using the catheter immediately.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2217-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2217-2023 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.
