Cardio Medical Products, Inc.… recallZ-1669-2013 · Cardio Medical Products · initiated Apr 26, 2013
Class II Terminated All recalls posted in July 2013
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Cardio Medical Products or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
FDA root cause category: Process control
What the company is doing
Cardio Medical Products, Inc. issued an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and segregate any product with the affected lot numbers and return affected product according to the instructions for product credit by contacting the Customer Service group at 1-800-962-9888, option 1, then option 2, and reference the recall letter to request a Return Goods Authorizing (RGA). Customers were instructed to complete the enclosed Verification Form and return it to Covidien by fax to 800-895-6140, even if they did not have any of the affected lots. Customers were also instructed to report any issues to the Quality Assurance Group to ensure proper device reporting procedures are followed. Customers with questions were instructed to call 1-800-962-9888, option 8, then ext 2500. For questions regarding this recall call 973-586-9500.
Recall details
- Recall number
- Z-1669-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 26, 2013
- Posted by the FDA
- Jul 8, 2013
- Recalling firm
- Cardio Medical Products
- Quantity
- 657 units
- Product code
- LDD
- FDA submissions
- K103159
- Distribution
- Nationwide Distribution
Product description
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
Code information (models, lots, serial numbers)
510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
Other devices under the same FDA submission
1 device cleared under K103159 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cardio Clear Z100Cardio-Medical Products, Inc. · Dc-Defibrillator, Low-Energy, (Including Paddles)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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