Skip to content

Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx… recallZ-1038-2012 · European Custom Manufacturing B.V. · initiated Apr 18, 2011

Terminated All recalls posted in February 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from European Custom Manufacturing B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number
Z-1038-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 18, 2011
Posted by the FDA
Feb 15, 2012
Recalling firm
European Custom Manufacturing B.V.
Quantity
2,120 individual units (106 boxes)
Product code
LDF
FDA submissions
K033858
Distribution
Nationwide Distribution-including the states of AL, AR, CA, FL, GA, KY, NC, NV, NY, TX, VA, and WI.

Product description

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 for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.

Code information (models, lots, serial numbers)

Model BM Lot numbers 1101044-10, 1012035-10, 1012036-10, 1011128-10, 1101023-10, 1101134-10, 1102035-10, 1102061-10, 1009089-10; -- Model V lot number: 1103066-10; -- Model VE lot numbers: 1101055-10, 1101008-10;  -- Model VF lot numbers: 1011092-10, 1011148-20, 1012038-10, 1101021-10, 1101136-10.

Other devices under the same FDA submission

5 devices cleared under K033858 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page