MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
FDA device recall Z-0831-03 · posted 2003-05-15 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr
- Action taken
- The firm notified each direct account by letter on 4/29/03 and, via letters of July 3 and July 11, 2003, extended the recall to three additional sizes of the catheter . Users were requested to check inventory, return the products to Boston Scientific and to reply regarding receipt of recall notification and the return of products.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 27 units
- Distribution
- CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,
- Date initiated
- 2003-04-29
- Date posted
- 2003-05-15
- Date terminated
- 2004-03-11
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROVASIVE MAXFORCE (K934697) | Boston Scientific Corp | 1994-05-16 |