Boston Scientific Recalls Extractor Pro RX Retrieval Balloon Catheter Due to Labeling Error
Boston Scientific is recalling one lot of Extractor Pro RX Retrieval Balloon Catheters because the device contains a syringe size larger than what is identified on the label.
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, and the source text identifies the issue as a labeling error regarding syringe size without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling one lot of the Extractor Pro RX Retrieval Balloon Catheter (9-12mm balloon). The recall involves 39 units distributed worldwide, including France, Great Britain, Spain, and Ireland.
The recall was initiated because the device contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label. The product is intended for use endoscopically to remove stones from the biliary system or to facilitate injection of contrast medium while occluding the duct with the balloon.
Healthcare providers and patients should stop using the affected lot (17673858) and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate…
- Manufacturer
- Boston Scientific Corporation
- 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: 17673858
Distribution
Distribution scope not specified by the agency.
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