| Date Initiated by Firm | January 31, 2003 |
|---|
| Date Posted | March 06, 2003 |
|---|
| Recall Status1 |
Terminated 3 on May 01, 2003 |
| Recall Number | Z-0625-03 |
|---|
| Recall Event ID |
25514 |
| 510(K)Number | K942269 |
|---|
| Product Classification |
Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
|
| Product | Medtronic AVE Everest PTCA Inflation Catheter 20 cc
Item #AC2200 |
|---|
| Code Information |
Lot Numbers: 122851, 12852, 122853 |
| FEI Number |
1220452
|
Recalling Firm/
Manufacturer |
Medtronic, Inc.
35-37A Cherry Hill Drive
Danvers MA 01923
|
| For Additional Information Contact | Fred L. Boucher
978-739-3116 |
|---|
Manufacturer Reason
for Recall | PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Medtronic AVE notified the two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped. |
|---|
| Quantity in Commerce | 602 units |
|---|
| Distribution | Japan |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LOX
|
|---|
