Cardiac Resynchronization Therapy Defibrillators — Class I medical device recall Z-0583-2018
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-0583-2018 |
|---|---|
| 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 | 00643169565272, 00643169705807 |
| Serial numbers | RPL200052H, RPL200534H, RPL201034H, RPL201039H, RPL201059H, RPL201234H, RPL201235H, RPL201236H, RPL201454H, RPL201645H, RPL201664H, RPW200289H |
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) 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-0583-2018. 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.