Recalls / —

—#124765

Product

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140

510(k) numbers

K102082

Affected lot / code info

Lot Number: 16230354

Why it was recalled

Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. For questions regarding this recall call 508-382-9555.

Recalling firm

Firm

Boston Scientific Corporation

Address

100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern

Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.

Timeline

Recall initiated

2013-12-18

Posted by FDA

2014-01-10

Terminated

2014-08-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #124765. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.