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Lower risk Medical device recall · FDA · Published September 12, 2017

Terumo Destination Guiding Sheath Catheter Recall: Marginally Outside Specification

Terumo recalls Destination Guiding Sheath catheter introducers with catalog number RSR06 that may have tucking depth marginally outside specifications. This could affect medical procedures.

🇺🇸 FDA recall #Z-0725-2018Medical deviceTerumo ›
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Recalling firmTerumo Medical Corporation950 Elkton Blvd · Elkton, MD 21921-5322
✎ GovInfoNow plain-language explainer

What happened, in plain English

Terumo is recalling Destination Guiding Sheath catheter introducers with catalog number RSR06. The issue is that the tucking depth feature might be slightly outside the upper specification, which could affect medical procedures. Read more at govinfonow.com/recall/73033-terumo-destination-guiding-sheath-catheter-recall-marginally-outside-specification.

Source Summary by GovInfoNow · govinfonow.com/recall/73033-terumo-destination-guiding-sheath-catheter-recall-marginally-outside-specification · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0725-2018

Cite this page

“Terumo Destination Guiding Sheath Catheter Recall: Marginally Outside Specification.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73033-terumo-destination-guiding-sheath-catheter-recall-marginally-outside-specification. Based on FDA recall #Z-0725-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0725-2018%22&limit=1).

Why it’s dangerous

The tucking depth feature of the catheter introducer is marginally outside the upper specification. This could potentially affect the device's performance during medical procedures, though the risk is low.

Who’s affected

Healthcare professionals using the catheter introducer for medical procedures are likely affected. Patients receiving procedures with this device may be at risk if the tucking depth is not within specifications.

How to tell if you have this one

Check for the catalog number RSR06 on the device. The product was used for introducing medical devices into blood vessels and was sold with lot number VK09, expiring January 31, 2020.

  • Brand
    Terumo
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for the catalog number RSR06 on the catheter introducer.

How this recall unfolded

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Sep 12, 201712. FDA classified it Class II: Feb 26, 201823. Published in FDA’s Enforcement Report: Mar 7, 201834. FDA terminated the recall: Aug 31, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What is the expiration date for the recalled product?

The expiration date is January 31, 2020.

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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-0725-2018 (September 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0725-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA