Datascope Sensation Plus 8Fr 50cc Balloon Catheter Recall: Undersized Dilator Risk

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Recalling firmDatascope Corporation15 Law Dr, N/A · Fairfield, NJ 07004-3206

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Datascope is recalling Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters that contain undersized dilators. This could cause improper catheter function during medical procedures, potentially leading to complications.

Why it’s dangerous

The catheter contains an undersized dilator, which may not properly expand during medical procedures. This could lead to improper function or complications if the catheter is used in a patient's circulatory system.

Who’s affected

Healthcare professionals using the Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter for medical procedures are most at risk. Patients receiving these catheters during treatment may be affected if the device is used.

How to tell if you have this one

Check the catheter's code information for the lot numbers listed: 10607567108605, 3000168086, 0684-00-0576-01 and similar combinations. The product is sold under the Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter name.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for the lot numbers 10607567108605, 3000168086, 0684-00-0576-01 or similar combinations on the catheter's code information.

✎ GovInfoNow

Questions people ask

What is the specific hazard with these catheters?

The catheters contain undersized dilators that may not expand properly during medical procedures.

How can I tell if my catheter is affected?

Check the code information for the lot numbers listed: 10607567108605, 3000168086, 0684-00-0576-01 or similar combinations.

What should I do if I have an affected catheter?

The recall record does not specify a remedy, so contact Datascope Corporation for further instructions.

Take action

Contact Datascope

We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1686-2022 — Datascope Datascope

Hello,

I own a Datascope that is covered by recall Z-1686-2022 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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Where this comes from

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.

Official source: FDA Recall #Z-1686-2022 (August 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1686-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Datascope Corporation recalls Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

Lower-risk recall