Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M001196620, Catalog # 19-662. Made i
FDA device recall Z-0388-2007 · posted 2007-02-07 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
- Action taken
- An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 18
- Distribution
- Nationwide.
- Date initiated
- 2006-12-13
- Date posted
- 2007-02-07
- Date terminated
- 2007-06-28
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6F MACH 1, MODEL 34356-XXX (K010874) | Boston Scientific Corp | 2001-06-21 |