Datascope recalls LINEAR 7.5Fr 40cc IAB with Accessories (Model 0684-00-0480-02) due to incorrect labeling that may delay critical therapy for hemodynamically unstable patients.
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
Datascope is recalling a specific model of intra-aortic balloon catheter because its labeling incorrectly states the balloon volume as 34cc instead of 40cc. This error could cause delays in treatment for patients who are unstable, potentially affecting their health outcomes.
The catheter's label incorrectly states the balloon volume as 34cc instead of 40cc. This could lead to confusion or delays in initiating critical therapy, which may impact patients who are more unstable hemodynamically.
Patients using this specific model of intra-aortic balloon catheter for medical procedures are at risk if the labeling error causes delays in therapy. Those with hemodynamically unstable conditions are most vulnerable.
Check for the model number 0684-00-0480-02 on the catheter's packaging or labels. The product was sold with lot codes including 3000210759 through 3000126591.
Verify the balloon volume on the internal label; it should read 40cc, not 34cc.
The catheter's internal label incorrectly states the balloon volume as 34cc instead of 40cc, which could cause delays in critical therapy for unstable patients.
Check for the model number 0684-00-0480-02 and lot codes listed in the recall notice, including 3000210759 through 3000126591.
Verify the label accuracy; if the volume is listed as 34cc, contact Datascope for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0131-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0131-2023 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.
