Merit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
Merit Medical Systems is recalling Scout MD Delivery Systems because the implantable clip may fail to deploy, preventing the reflector from functioning as intended.
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 source identifies a functional defect where the implantable clip may fail to deploy, preventing the reflector from functioning as intended. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Merit Medical Systems, Inc. is recalling Scout MD Delivery Systems (REF MDS05A-01, MDS05C-01, MDS10C-01). The recalled items are sterile, prescription-only delivery systems used with the SCOUT MD Surgical Guidance System.
The recall was initiated because the implantable clip may experience difficulties deploying. This issue could prevent the reflector from functioning as intended during use. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The affected lots are MDS05A-01 (Lot H3515477), MDS05C-01 (Lot H3507786), and MDS10C-01 (Lot H3507794). These products were distributed in Arizona, California, Florida, Indiana, Louisiana, Nevada, and Rhode Island. Healthcare providers and facilities should stop using the affected lots and contact Merit Medical Systems for instructions on return or replacement.
The recalled product
- Product
- Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
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 (3)
- MDS05A-01-Lot: H3515477/UDI:00884450392850
- MDS05C-01 - Lot: H3507786/UDI:00884450392874
- MDS10C-01 - Lot:H3507794/UDI:00884450392911
Distribution
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