Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
FDA device recall Z-0711-2014 · posted 2014-01-10 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
- Action taken
- 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
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 38 units
- Distribution
- Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
- Date initiated
- 2013-12-18
- Date posted
- 2014-01-10
- Date terminated
- 2014-08-19
- Location
- Marlborough, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 (K102082) | Boston Scientific Corp | 2010-08-23 |