EkoSonic Endovascular Device Kit Mislabeled: Boston Scientific Recall
Boston Scientific is recalling 10 units of the EkoSonic Kit endovascular device due to product mislabeling. Affected devices were distributed to medical facilities in 10 US states.
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: This FDA Class II device recall involves a labeling error without reported adverse events or injuries. The limited distribution (10 units across 10 states) and absence of clinical harm place this in the moderate-severity category per the rubric criterion for minor labeling errors.
Plain-English summary
Boston Scientific Corporation is recalling 10 units of the EkoSonic Kit (106cm, 12cm TZ) endovascular device because the product may be mislabeled. The affected devices were distributed to medical facilities in California, Connecticut, Georgia, Iowa, Illinois, Indiana, New York, Ohio, Texas, and Wyoming.
The affected lot numbers are: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230, 8035075231, 8035075232, 8035075233, and 8035075234 (UPN: 500-55112; GTIN: 858593006134).
Healthcare facilities that received devices with these lot numbers should stop use and contact Boston Scientific Corporation for instructions on product return or replacement. No adverse events or injuries have been reported.
The recalled product
- Product
- EkoSonic Kit 106cm, 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 la
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Endovascular
- 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 (9)
- UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225
- 8035075226
- 8035075227
- 8035075228
- 8035075229
- 8035075230 8035075231
- 8035075232
- 8035075233
- 8035075234
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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