Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
FDA device recall Z-0109-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
- Action taken
- Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 153
- Distribution
- Nationwide
- Date initiated
- 2007-09-10
- Date posted
- 2007-10-31
- Date terminated
- 2007-12-20
- Location
- Marlborough, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENEGADE HI-FLO MICROCATHETER (K000177) | Boston Scientific Corp | 2000-04-07 |