Datascope recalls Mega 7.5FR 30cc Intra-Aortic Balloon Catheters due to missing contraindications in instructions. This may lead to unsafe use during counterpulsation therapy.
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 30cc Intra-Aortic Balloon Catheters because the U.S. Instructions For Use lacked the Contraindications section. This could mean users might not know when the device shouldn't be used, potentially causing unsafe medical procedures.
The missing Contraindications section in the Instructions For Use means users might not know when the device shouldn't be used. This could lead to unsafe medical procedures if the catheter is applied in situations where it's contraindicated.
Healthcare professionals using the catheter for counterpulsation therapy are most at risk. Patients receiving this treatment may be affected if the instructions are incomplete.
Check for the product code 0684 00 0294 01U or 0684 00 0294 02U on the catheter packaging. The device is used for counterpulsation therapy in the aorta.
Check if the Instructions For Use include the Contraindications section as required by the U.S. regulatory standards.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon Catheter was missing the Contraindications section, which could lead to unsafe use during counterpulsation therapy.
Check if the Instructions For Use include the Contraindications section. If missing, contact Datascope Corporation for guidance.
The recall is due to missing instructions, not an immediate risk of serious injury. However, incomplete instructions could lead to unsafe use.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1384-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1384-2018 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.
