Terumo Destination Renal Guiding Sheath Recalled for Missing Coating
Terumo Medical Corporation is recalling Destination Renal Guiding Sheaths because the distal end may lack the labeled 5 cm of coating, potentially making device navigation difficult.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no complaints or patient-related incidents have been reported, and the hazard is a functional difficulty rather than a direct injury risk, fitting the Moderate criteria for low-risk issues without reported harm.
Plain-English summary
Terumo Medical Corporation is voluntarily recalling 5,252 units of Destination Renal Guiding Sheaths. The recall is due to an internal investigation and testing that revealed the distal end of certain lots may not contain the labeled 5 cm of coating. The affected lots are RN19, RN26, and RP03, identified by Terumo Product Code RSR01.
The lack of coating could render it difficult to navigate the device to the target vasculature. The product is intended for the introduction of interventional and diagnostic devices into the human vasculature. The recall covers units distributed nationwide.
There have been no complaints or patient-related incidents reported. Healthcare providers and facilities should stop using the affected lots and contact Terumo Medical Corporation for further instructions on the recall.
The recalled product
- Product
- Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
- Manufacturer
- Terumo Medical Corporation
- Hazard
- Affected units
- 5,252
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
Distribution
Distributed nationwide across the United States.
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