Medtronic Recalls VenaSeal Closure Systems Due to Adhesive Delivery Issues
Medtronic is recalling 154,152 VenaSeal Closure Systems because the dispensing systems may not effectively advance adhesive through the delivery catheter.
What this means for you
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 III, which by definition is unlikely to cause adverse health consequences, and the source text does not report any injuries or illnesses.
Plain-English summary
Medtronic Inc. is recalling 154,152 units of the VenaSeal Closure System. The recall was initiated after the firm received an increased number of reports indicating that the VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
The affected products include Model Numbers SP-101, VS-402, and VS-404. The source text notes that Model Number VS-403 is not approved in the U.S. and has not been distributed outside of the United States, but it is included in the scope of the corrective action as it is launched in other regions beginning Summer 2021. The affected units were distributed nationwide to Massachusetts, New York, Vermont, New Hampshire, and Maine.
Consumers and healthcare providers should check their inventory for the specific serial numbers and model numbers listed in the official recall notice. If a unit is affected, it should be removed from use and returned to Medtronic or the distributor according to the firm's instructions.
The recalled product
- Product
- VenaSeal Closure System
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 154,152
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 (20)
- Model Number SP-101: GTIN 20643169986279
- Serial Numbers: 54143
- 54145
- 54146
- 54147
- 54148
- 54149
- 54150
- 54151
- 54152
- 54396
- 54397
- 54398
- 54399
- 54417
- 54418
- 54419
- 54420
- 54618
- 54619
Distribution
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