CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Destination Renal Guiding Sheath Intended recalled by Terumo Medical
Terumo Medical is recalling Destination Renal Guiding Sheath Intended for the introduction of interventional and, distributed nationwide in the US. The recall was initiated on 6 Nov 2015 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-2033-2017
- FDA event ID
- 76939
- Recalling firm
- Terumo Medical, Elkton, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2015
- FDA classified
- 4 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Nov 2015 | Recall initiated by company | |
| 4 May 2017 | Classified by FDA | +545 days |
| 10 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Where it was distributed
Nationwide Distribution.
Stores named: Target
Questions about this recall
Is Destination Renal Guiding Sheath Intended for the introduction of interventional and recalled?
Yes. Terumo Medical recalled Destination Renal Guiding Sheath Intended for the introduction of interventional and on 6 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-2033-2017.
Why was it recalled?
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Which lots are affected?
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
Where was it sold?
Nationwide Distribution.
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 21 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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