Medtronic Dual Chamber Temporary External Pacemaker recall
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for…
Why was Medtronic Dual Chamber Temporary External Pacemaker recalled?
Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
serial numbers equal or lower than DJH009999P
- Product
- Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for…
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Quantity
- 6040 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MM, MS, MO, MT, NE NV,N, NM, NY, NC, ND, OH,OK, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, PR, VI and the countries of:Australia, Austria, Bahamas, Belgium, Bolivia ,Botswana, Brazil ,Brunei, Darussalam, Bulgaria, Burkina Faso, Canada, Colombia, Croatia, Cyprus, Czech Republic, Denmark,, Dominican Republic, Egypt, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Luxembourg, Macedonia, Malaysia, Mauritius, Morocco, Mozambique, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua, New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre and Miquelon,Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Yemen. .
- Recall date
- April 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)