The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsu
FDA device recall Z-0410-06 · posted 2006-02-01 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
- Action taken
- All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- individual qty in US:376, Worldwide distribution pending.
- Distribution
- Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia L
- Date initiated
- 2005-12-07
- Date posted
- 2006-02-01
- Date terminated
- 2007-08-10
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM (K052038) | Boston Scientific Corporation | 2005-08-16 |