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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · defective device
See all →- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18
- ModerateBeaver Visitec Recalls CustomEyes Procedure Packs with Sol-M Syringes
FDA (Devices) · 2024-09-04
- HighPhilips IntelliVue MX40 Patient Monitor Recalled for Manufacturing Defects
FDA (Devices) · 2021-06-02
- ModerateA&E Medical Thorecon Plating System Kits Recalled for Molding Defect
FDA (Devices) · 2019-11-06
- ModeratePOM Medical Recalls Procedural Oxygen Masks Due to Defective Re-breather Bags
FDA (Devices) · 2019-11-06
Similar recalls
- ModerateBoston Scientific Retrieval Balloon Catheter Recalled for Incorrect Injection Labeling
FDA (Devices) · 2017-07-12
- ModerateBoston Scientific Retrieval Balloon Catheter Recalled for Labeling Error
FDA (Devices) · 2017-07-12
- ModerateBoston Scientific Recalls Extractor Pro RX Retrieval Balloon Catheter Due to Labeling Error
FDA (Devices) · 2015-07-08
- ModerateExtractor Pro RX Retrieval Balloon Catheter incorrectly labeled
FDA (Devices) · 2025-10-01
- HighBoston Scientific Recalls Hurricane RX Biliary Balloon Catheters Due to Detachment Risk
FDA (Devices) · 2020-11-04
- HighBoston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
FDA (Devices) · 2013-07-17