Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters
Boston Scientific is recalling 39 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 3/5 (High).
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 involves a medical device with a functional defect (incorrect skive hole location or balloon size) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 39 units of the Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above (UPN: M00547100). The recall was initiated because the devices may have the incorrect skive hole location or balloon size.
The affected units are from Lot Number 16231178. These devices were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as internationally. The catheters are used endoscopically to remove stones from the biliary system or to facilitate the injection of contrast medium while occluding the duct.
Healthcare providers and consumers should stop using the affected devices immediately. Boston Scientific is the recalling firm responsible for this action.
The recalled product
- Product
- Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while…
- 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 Number:16231178
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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