Implantable Cardioverter Defibrillators — Class I medical device recall Z-0588-2018
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2018-02-28, distributed nationwide. Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs
| Recall number | Z-0588-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2017-12-19 |
| Classified | 2018-04-19 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2021-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 951 devices |
| UPC / GTIN / UDI-DI | 00643169566422, 00643169566446, 00643169717206, 00643169717213, 00643169929913 |
| Serial numbers | CWG200147H, CWG200402H, CWG200403H, CWG200404H, CWG200406H, CWG200897H, CWG200898H, CWG200899H, CWG202225H, CWG202244H, CWG202761H, CWG202762H, CWG203250H, CWG203455H, CWJ200155H, PKX201092H, PKX201561H, PKX201910H, PKX202355H, PKX202386H, PKX202448H, PKX202879H, PKX202881H, PKX202882H, PKX202883H and 82 more |
Product
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Reason for recall
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0588-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.