Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporar...
FDA Device Recall #Z-1661-2014 — Class II — April 29, 2014
Recall Summary
| Recall Number | Z-1661-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 29, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 16,337 (8,989 US; 7,348 OUS) |
Product Description
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).
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.
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.
Lot / Code Information
serial numbers: PEP001001K, PEP001001P, PEP001002K, PEP001002P, PEP001003K, PEP001003P, PEP001004K, PEP001004P, PEP001005K, PEP001005P, PEP001006K, PEP001006P, PEP001007K, PEP001007P, PEP001008K, PEP001008P, PEP001009K, PEP001009P, PEP001010K, PEP001010P, PEP001011K, PEP001011P, PEP001012K, PEP001012P, PEP001013K, PEP001013P, PEP001014K, PEP001014P, PEP001015K, PEP001015P, PEP001016K, PEP001016P, PEP001017K, PEP001017P, PEP001018K, PEP001018P, PEP001019K, PEP001019P, PEP001020K, PEP001020P, PEP001021K, PEP001021P, PEP001022K, PEP001022P, PEP001023K, PEP001023P, PEP001024K, PEP001024P, PEP001025K, PEP001025P, PEP001026K, PEP001026P, PEP001027K, PEP001027P, PEP001028K, PEP001028P, PEP001029K, PEP001029P, PEP001030K, PEP001030P, PEP001031K, PEP001031P, PEP001032K, PEP001032P, PEP001033K, PEP001033P, PEP001034K, PEP001034P, PEP001035K, PEP001035P, PEP001036K, PEP001036P, PEP001037K, PEP001037P, PEP001038K, PEP001038P, PEP001039K, PEP001039P, PEP001040K, PEP001040P, PEP001041K, PEP001041P, 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PEP002715P, PEP002716P, PEP002717P, PEP002718P, PEP002719P, PEP002720P, PEP002721P, PEP002722P, PEP002723P, PEP002724P, PEP002725P, PEP002726P, PEP002727P, PEP002728P, PEP002729P, PEP002730P, PEP002731P, PEP002732P, PEP002733P, PEP002734P, PEP002735P, PEP002736P, PEP002737P, PEP002738P, PEP002739P, PEP002740P, PEP002741P, PEP002742P, PEP002743P, PEP002744P, PEP002745P, PEP002746P, PEP002747P, PEP002748P, PEP002749P, PEP002750P, PEP002751P, PEP002752P, PEP002753P, PEP002754P, PEP002755P, PEP002756P, PEP002757P, PEP002758P, PEP002759P, PEP002760P, PEP002761P, PEP002762P, PEP002763P, PEP002764P, PEP002765P, PEP002766P, PEP002767P, PEP002768P, PEP002769P, PEP002770P, PEP002771P, PEP002772P, PEP002773P, PEP002774P, PEP002775P, PEP002776P, PEP002777P, PEP002778P, PEP002779P, PEP002780P, PEP002781P, PEP002782P, PEP002783P, PEP002784P, PEP002785P, PEP002786P, PEP002787P, PEP002788P, PEP002789P, PEP002790P, PEP002791P, PEP002792P, PEP002793P, PEP002794P, PEP002795P, PEP002796P, PEP002797P, PEP002798P, PEP002799P, PEP002800P, PEP002801P, PEP002802P, PEP002803P, PEP002804P, PEP002805P, PEP002806P, PEP002807P, PEP002808P, PEP002809P, PEP002810P, PEP002811P, PEP002812P, PEP002813P, PEP002814P, PEP002815P, PEP002816P, PEP002817P, PEP002818P, PEP002819P, PEP002820P, PEP002821P, PEP002822P, PEP002823P, PEP002824P, PEP002825P, PEP002826P, PEP002827P, PEP002828P, PEP002829P, PEP002830P, PEP002831P, PEP002832P, PEP002833P, PEP002834P, PEP002835P, PEP002836P, PEP002837P, PEP002838P, PEP002839P, PEP002840P, PEP002841P, PEP002842P, PEP002843P, PEP002844P, PEP002845P, PEP002846P, PEP002847P, PEP002848P, PEP002849P, PEP002850P, PEP002851P, PEP002852P, PEP002853P, PEP002854P, PEP002855P, PEP002856P, PEP002857P, PEP002858P, PEP002859P, PEP002860P, PEP002861P, PEP002862P, PEP002863P, PEP002864P, PEP002865P, PEP002866P, PEP002867P, PEP002868P, PEP002869P, PEP002870P, PEP002871P, PEP002872P, PEP002873P, PEP002874P, PEP002875P, PEP002876P, PEP002877P, PEP002878P, PEP002879P, PEP002880P, 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PEP002964P, PEP002965P, PEP002966P, PEP002967P, PEP002968P, PEP002969P, PEP002970P, PEP002971P, PEP002972P, PEP002973P, PEP002974P, PEP002975P, PEP002976P, PEP002977P, PEP002978P, PEP002979P, PEP002980P, PEP002981P, PEP002982P, PEP002983P, PEP002984P, PEP002985P, PEP002986P, PEP002987P, PEP002988P, PEP002989P, PEP002990P, PEP002991P, PEP002992P, PEP002993P, PEP002994P, PEP002995P, PEP002996P, PEP002997P, PEP002998P, PEP002999P, PEP003000P, PEP003001P, PEP003002P, PEP003003P, PEP003004P, PEP003005P, PEP003006P, PEP003007P, PEP003008P, PEP003009P, PEP003010P, PEP003011P, PEP003012P, PEP003013P, PEP003014P, PEP003015P, PEP003016P, PEP003017P, PEP003018P, PEP003019P, PEP003020P, PEP003021P, PEP003022P, PEP003023P, PEP
Other Recalls from Medtronic Inc. Cardiac Rhythm Disease...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0022-2016 | Class II | Medtronic Medical Device Identification Card fo... | Sep 15, 2015 |
| Z-2777-2015 | Class II | Medtronic CryoConsole, models 106A3, 106E2, and... | Sep 1, 2015 |
| Z-1365-2015 | Class II | Covidien Trellis 6 and Trellis 8 Peripheral Inf... | Mar 23, 2015 |
| Z-1356-2015 | Class II | Medtronic Dual Chamber Temporary External Pacem... | Mar 17, 2015 |
| Z-1276-2015 | Class I | Medtronic, 10 Fr FlexCath Select Steerable Shea... | Feb 23, 2015 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.