Boston Scientific Retrieval Balloon Catheter Recalled for Labeling Error
Boston Scientific is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter because the label incorrectly identifies the injection location.
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: The recall is classified as FDA Class II, but the source text describes a labeling error regarding injection location without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Boston Scientific Corporation is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above (UPN: M00547300). The recall involves Lot Number 19343203, which has an expiration date of 6/30/2018.
The recall was initiated because the label on the affected devices incorrectly identifies the injection location. Specifically, the label states the location is "above" the balloon when it should be below, and "below" the balloon when it should be above.
The affected units were distributed in Michigan and Missouri, as well as in Austria, France, Great Britain, Italy, Spain, and Sweden. Users should stop using the affected devices and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 39
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 (1)
- Lot Number: 19343203 Exp.: 6/30/2018
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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