Boston Scientific Retrieval Balloon Catheter Recalled for Incorrect Injection Labeling
Boston Scientific is recalling 32 units of Extractor Pro RX-S Retrieval Balloon Catheters because the labels incorrectly identify the injection location relative to the balloon.
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 without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
Boston Scientific Corporation is recalling 32 units of the Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below (UPN: M00547340). The recall involves Lot Number 19343209, which has an expiration date of 6/30/2018. The devices were distributed in Michigan and Missouri, as well as in Austria, France, Great Britain, Italy, Spain, and Sweden.
The recall was initiated because the labels on the affected devices incorrectly identify the injection location. The labels state "above" the balloon when the injection should be below, and "below" the balloon when the injection should be above. This labeling error could lead to incorrect device usage.
Healthcare providers and facilities that have received these specific units should stop using them and contact Boston Scientific Corporation for instructions on how to return the devices. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 32
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: 19343209 Exp: 6/3 0/2018
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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