Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters
Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling 38 units of the Extractor Pro XL Retrieval Balloon Catheter 12-15 mm (UPN: M00547110). The recall was initiated because the devices may have the incorrect skive hole location or balloon size.
The affected units, identified by Lot Number 16231174, were distributed nationwide in the United States, including Puerto Rico, as well as internationally. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should stop using the affected catheters and contact Boston Scientific Corporation for further instructions on the recall.
The recalled product
- Product
- Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 38
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: 16231174
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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