Boston Scientific Recalls EkoSonic Endovascular Device Kit for Mislabeling
Boston Scientific is recalling 10 EkoSonic Endovascular Device Kits due to mislabeling. The affected kits were distributed to healthcare facilities in 10 U.S. states.
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: This is an FDA Class II recall involving a labeling defect with no reported illnesses or injuries. Per the severity rubric, labeling errors without documented harm constitute a Moderate severity issue.
Plain-English summary
Boston Scientific Corporation is recalling 10 EkoSonic Kit 135cm, 12cm TZ Endovascular Device units (Lot Numbers: 8035075263–8035075272) due to mislabeling of the product. The EkoSonic Endovascular Device is a medical device used in vascular procedures.
The affected kits were distributed in the United States to healthcare facilities in California, Connecticut, Georgia, Iowa, Illinois, Indiana, New York, Ohio, Texas, and Wyoming. No illnesses or injuries have been reported in connection with this recall.
Healthcare providers who have received these kits should not use them and should contact Boston Scientific for return authorization. Patients who have been treated with these devices should consult with their healthcare provider if they have concerns.
The recalled product
- Product
- EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 10
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 (10)
- UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263
- 8035075264
- 8035075265
- 8035075266
- 8035075267
- 8035075268
- 8035075269
- 8035075270
- 8035075271
- 8035075272
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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