Medtronic, Inc.
Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH
| Date | May 9, 2003 (initiated Mar 17, 2003) |
| Status | Terminated |
| Reason | The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label. |
| Root cause | Other |
| Action | Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field. |
| Distribution | AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981198 | MEDTRONIC ZUMA GUIDING CATHETER Medtronics Interventional Vascular, Aug 7, 1998 |