—#136204

Product

Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K102082
Affected lot / code info: Lot: 17673858

Why it was recalled

One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.

Root cause (FDA determination)

Employee error

Action the firm took

Boston Scientific sent an Urgent Medical Device Recall Removal letter dated April 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected product in their inventory, quarantine the affected product immediately and return to Boston Scientific in accordance with the enclosed recall instructions. Customers will receive replacements for all recalled product that is returned to Boston Scientific. Customers were instructed to forward the recall notification to their customers. Customers with questions were instructed to contact their local sales representative. For questons regarding this recall call 763-494-1133.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .

Timeline

Recall initiated: 2015-04-27
Posted by FDA: 2015-07-01
Terminated: 2016-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.