FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
- Recall number
- Z-0711-2014
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
- Status
- Terminated
- Initiated
- 2013-12-18
- Posted
- 2014-01-10
- Terminated
- 2014-08-19
- Reason
- Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
- Root cause
- Process control
- 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.
- Quantity
- 38 units
- Distribution
- Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
- Lot, serial or model codes
- Lot Number: 16231174
- 510(k) numbers
- ["K102082"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28