Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
FDA Recall Z-0711-2014 · Posted 2014-01-10
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2013-12-18
Date Terminated2014-08-19
Product Quantity38 units
Reason for Recall
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.