Datascope recalls Mega 7.5FR 40cc intra-aortic balloon catheters due to missing contraindications in instructions. This could lead to unsafe use during heart therapy. Affected units include model 0684 00 0295 01U and 0684 00 0295 02U.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Datascope is recalling its Mega 7.5FR 40cc intra-aortic balloon catheters because the instructions for use lacked the contraindications section. This missing information could lead to unsafe medical procedures if used without proper warnings.
The instructions for use did not include contraindications, meaning potential risks like unsafe use during heart therapy could occur. This could lead to complications if the catheter is used without knowing which conditions make it unsafe.
Healthcare providers using the catheter for heart therapy are most at risk. Patients receiving this treatment may be affected if their care team uses the recalled product.
Check for model numbers 0684 00 0295 01U or 0684 00 0295 02U on the catheter packaging. The product is used for heart therapy to improve blood flow.
Verify if the instructions for use include the contraindications section.
The instructions for use were missing the contraindications section, which could lead to unsafe use during heart therapy.
Model numbers 0684 00 0295 01U and 0684 00 0295 02U.
No specific stop-use instruction is given; check if the instructions include contraindications.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1383-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1383-2018 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.
