Recall Z-0831-03 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific Corporation
MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
| Date | May 15, 2003 (initiated Apr 29, 2003) |
| Status | Terminated |
| Reason | Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr |
| Root cause | Other |
| Action | 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. |
| Quantity | 27 units |
| Distribution | CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934697 | MICROVASIVE MAXFORCE Boston Scientific Corp, May 16, 1994 |