Prelude Roadster Guide Sheaths Recalled Due to Instruction Defect
Merit Medical Systems is recalling Prelude Roadster Guide Sheaths due to an instructional defect. Older instructions directing tight connection assembly may cause over-tightening, leading to swivel nut detachment.
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: This is an FDA Class II recall of a medical device where a labeling defect (incorrect instructions) could lead to component failure during clinical use. Although no adverse events are reported in the source, the device is used in vascular procedures where swivel nut detachment poses a risk of harm.
Plain-English summary
Merit Medical Systems, Inc. is recalling Prelude Roadster Guide Sheath devices due to an instructional defect. The Prelude Roadster Guide Sheath is a medical device introducer used for guiding interventional and diagnostic devices into peripheral and coronary blood vessels.
The recall is due to an instruction error in older versions of the Instruction for Use (IFU). The IFU instructs users to ensure the luer and sheath are tightly connected before use. This instruction may cause users to over-tighten the luer, which can result in the swivel nut detaching from the HVA (hub valve adapter) body.
The recall affects multiple catalog codes and lot numbers of the device, with worldwide distribution. Healthcare providers and patients who use these devices should verify their product lot numbers against the FDA recall notice.
Users should stop using affected devices and contact Merit Medical Systems or the FDA with questions or to report any adverse events.
The recalled product
- Product
- Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP…
- Manufacturer
- Merit Medical Systems, Inc.
Distribution
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