Recall Z-1038-2012 ยท LDF Electrode, Pacemaker, Temporary
European Custom Manufacturing B.V.
Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended f
| Date | Feb 15, 2012 (initiated Apr 18, 2011) |
| Status | Terminated |
| Reason | The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality. |
| Root cause | Process design |
| Action | ECM sent an "ECMbv RECALL OF MCE TEMPORARY PACING WIRES" letter dated May 2, 2011 to all affected customers. Customers were also informed of a potential problem via e-mail and/or phone between April 18 and 21, 2011. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to place the affected product on hold and to return the product to the firm. For questions on this matter, contact ECM or MCE Customer Service at 1-877-886-1985. |
| Quantity | 2,120 individual units (106 boxes) |
| Distribution | Nationwide Distribution-including the states of AL, AR, CA, FL, GA, KY, NC, NV, NY, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE European Custom Manufacturing BV, Jul 12, 2004 |