Boston Scientific Extractor Pro XL Retrieval Balloon Catheter Recall
Boston Scientific is recalling 34 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.
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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 34 units of the Extractor Pro XL Retrieval Balloon Catheter 12-15 mm (UPN: M00547140). The recall is due to the possibility that the devices may have the incorrect skive hole location or balloon size.
The affected units are identified by Lot Number 16230354. These devices were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as internationally.
Healthcare providers and consumers should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement.
The recalled product
- Product
- Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 34
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: 16230354
Distribution
Part of a larger recall action
This product is one of 3 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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