Merit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing
Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a sizing mismatch that could affect medical procedure outcomes, but no actual harm has been documented, per rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling Prelude Guide Sheath Roadster devices (REF PG6F45S018, 6F 0.087", 45 cm, STERILE EO) due to a labeling defect that could result in the use of incorrectly-sized medical devices during clinical procedures.
Some sheaths labeled with .018 dilators may contain .038 dilators instead. If a physician selects a sheath based on the label and unknowingly uses an incorrectly-sized device, it could affect the outcome of the procedure.
The affected lot is H2817178 (UDI: 00884450770771), with 27 units distributed worldwide to the United States (California statewide distribution), New Zealand, and Canada. Physicians and healthcare facilities should not use sheaths from this lot. Contact Merit Medical Systems, Inc. for return instructions.
The recalled product
- Product
- Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 27
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)
- Lot # H2817178/ UDI: 00884450770771
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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