JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
Jenavalve Technology Inc. is recalling 108 units of the JenaValve Trilogy Delivery Catheter due to a defect that may prevent heart valve deployment.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a defect that may result in the inability to deploy a heart valve device. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Jenavalve Technology Inc. is recalling 108 units of the JenaValve Trilogy Delivery Catheter, Size 25MM (REF: TRILOGY-DC-M). The recall is due to a potential defect where the sleeve liner may separate, which could result in difficulty or inability to deploy the heart valve device.
The affected products were distributed nationwide in the United States in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, and WA, as well as in Germany, Denmark, Great Britain, and Italy. The specific lot numbers involved are DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, and DS-051526-001.
Healthcare providers and consumers should stop using the affected catheters and contact Jenavalve Technology Inc. for further instructions or a replacement.
The recalled product
- Product
- JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
- Manufacturer
- Jenavalve Technology Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 108
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 (7)
- GTIN - 00850000898141/Lot # DS-040826-005
- DS-040926-002
- DS-042326-001
- DS-042826-007
- DS-042926-008
- DS-050826-005
- DS-051526-001
Distribution
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