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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:124763

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.

Official recall number

Z-0710-2014

Evidence summary

Product code
FGE
Recall status
Terminated
Event initiated
December 18, 2013
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0710-2014

Field note

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