Medtronic — Class II medical device recall Z-2200-2016
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2016-07-20, distributed nationwide. This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of F
| Recall number | Z-2200-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN, United States |
| Recall initiated | 2016-06-16 |
| Classified | 2016-07-12 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2018-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BG, CA, CH, CO, DE, DZ, ES, FR, GB, HK, HU, IE, IL, IT, JO, NL, NO, PL, PT, QA, RS, SA, SE, SI, TR, ZA |
| Model numbers | 6416 |
Product
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.
Reason for recall
This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.