Terminated

Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

FDA Recall Z-1661-2014 · Posted 2014-05-24

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management

Recall StatusTerminated

Product CodeLWP

Date Initiated2014-04-29

Date Terminated2014-10-08

Product Quantity16,337 (8,989 US; 7,348 OUS)

Reason for Recall

Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.

Firm Action

Consignees were sent a Medtronic "Urgent Medical Device Correction" letter dated April 2014. The letter was addressed to Risk Manger, Health Care Professional. The letter included the Issue Description, Root Cause, Potentially Affected 5348 EPGs within the Serial Number Ranges, Malfunction Indications, and Recommended Actions. For questions related to EPG service policy or purchasing a replacement EPG, customers should contact your Medtronic representative. For technical questions, please call Instruments Technical Service at (1-800)638-1991. Medtronic asks that customers complete and sign the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or e-mail to [email protected].

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.