Datascope SENSATION PLUS 8F Insertion Kit Recall: Undersized Dilator Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Datascope is recalling insertion kits for SENSATION PLUS 8F catheters that contain undersized dilators. This could cause injury during medical procedures if the dilator is too small.

Why it’s dangerous

Undersized dilators in the kit may not properly expand the catheter during insertion, potentially causing injury to blood vessels. This risk is specific to the medical procedure being performed.

Who’s affected

Healthcare professionals using the SENSATION PLUS 8F catheter insertion kits with specific lot numbers are affected. Patients receiving these procedures may be at risk if the dilator is undersized.

How to tell if you have this one

Check the kit's code information for lot numbers: 10607567108599, 3000170709, 0884-00-0019-23 or 3000182611, 0884-00-0019-23 or 3000202083, 0884-00-0019-23. These kits were sold with specific lot numbers.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Numbers
Look for lot numbers 10607567108599 on the kit's code information.

✎ GovInfoNow

Questions people ask

What is the hazard with these kits?

The kits contain undersized dilators that may not properly expand the catheter during insertion, potentially causing injury to blood vessels.

How can I tell if I have an affected kit?

Check the kit's code information for lot numbers: 10607567108599, 3000170709, 0884-00-0019-23 or 3000182611, 0884-00-0019-23 or 3000202083, 0884-00-0019-23.

Do I need to stop using these kits?

The recall does not specify a stop-use action; affected kits should be checked for the specific lot numbers.

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-1687-2022 — Datascope Datascope

Hello,

I own a Datascope that is covered by recall Z-1687-2022 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-1687-2022 (August 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1687-2022 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.

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