Datascope recalls Mega 8FR 50cc intra-aortic balloon catheters due to missing contraindications in instructions. This could lead to unsafe use during counterpulsation therapy. Affected units include model 0684 00 0296 01U and 0684 00 0296 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 8FR 50cc intra-aortic balloon catheters because the U.S. Instructions For Use missed the Contraindications section. This could lead to unsafe use during counterpulsation therapy for heart conditions.
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 device is used in situations where it's contraindicated.
Patients using the Mega 8FR 50cc intra-aortic balloon catheter for heart therapy are most at risk. Healthcare providers who use this device for counterpulsation therapy may also be affected.
Check for the model numbers 0684 00 0296 01U or 0684 00 0296 02U on the catheter packaging. The device is used for counterpulsation therapy in heart conditions.
Review the U.S. Instructions For Use to confirm the contraindications section is present.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon Catheter was missing the Contraindications section.
The affected models are 0684 00 0296 01U and 0684 00 0296 02U.
The recall record does not specify a remedy.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1385-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1385-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
