CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Destination Guiding Sheath catheter introducer recalled
Terumo Medical is recalling Destination Guiding Sheath catheter introducer. The recall was initiated on 12 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0725-2018
- FDA event ID
- 79167
- Recalling firm
- Terumo Medical, Elkton, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2017
- FDA classified
- 26 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 12 Sep 2017 | Recall initiated by company | |
| 26 Feb 2018 | Classified by FDA | +167 days |
| 7 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Product as listed by the FDA
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
Where it was distributed
To be added.
Questions about this recall
Why was it recalled?
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Which lots are affected?
Lot: VK09, Expiration Date: 31-Jan-2020
Where was it sold?
To be added.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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