Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00
FDA device recall Z-1941-2015 · posted 2015-07-01 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 39 units
- Distribution
- Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
- Date initiated
- 2015-04-27
- Date posted
- 2015-07-01
- Date terminated
- 2016-01-27
- Location
- Marlborough, MA
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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 |