Recall Z-0710-2014— Boston Scientific Corporation

Name: FDA recall Z-0710-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-18

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2013-12-18, terminated 2014-08-19. It names one FDA 510(k) clearance: K102082. 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 occluding the duct with the balloon.. Reason: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-12-18
Terminated: 2014-08-19
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102082 — EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470Boston Scientific Corp·cleared 2010-08-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.