Elana Catheter Sizer 2.0 Recalled for Unapproved Distribution
Elana, Inc. is recalling three Elana Catheter Sizer 2.0 devices because they were distributed in interstate commerce without FDA approval.
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: The recall involves the distribution of an unapproved medical device, which poses a risk of harm as the device has not been evaluated for safety and effectiveness. No injuries or illnesses are reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elana, Inc. is recalling three units of the Elana Catheter Sizer 2.0. This medical device is designed to aid surgeons in assessing the bypass graft of the ELANA technique. The specific units involved are Model 280 with serial numbers 776, 706, and 758.
The recall was initiated because the devices were distributed into interstate commerce without FDA approval. The affected units were distributed in the states of Pennsylvania, Texas, and New York.
Healthcare facilities and consumers who possess these specific serial numbers should stop using the devices and contact Elana, Inc. for instructions on return or replacement. No specific injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
- Manufacturer
- Elana, Inc.
- Hazard
- Affected units
- 3
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 (4)
- Model 280
- S/N 776
- S/N 706
- S/N 758
Distribution
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