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 occluding the duct with the balloon.
Reported: January 22, 2014 Initiated: December 18, 2013 #Z-0710-2014
Product Description
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 occluding the duct with the balloon.
Reason for Recall
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 39 units
- Distribution
- Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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 occluding the duct with the balloon.. Recalled by Boston Scientific Corporation. Units affected: 39 units.
Why was this product recalled? ▼
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0710-2014.
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