CardioMEMS HF System Hospital and Patient Electronics Units: — Class II medical device recall Z-2522-2018
Terminated recall by Abbott Laboratories, Inc., reported 2018-08-01. Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000)
| Recall number | Z-2522-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc., Atlanta, GA, United States |
| Recall initiated | 2018-06-14 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2021-09-08 |
| Countries outside the US | BE, CA, DE, FR, GB, IE, NL |
| Quantity | 2,521 units |
| UPC / GTIN / UDI-DI | 05414734509800, 05415067029331 |
| Serial numbers | M170908359, M170908360, M170908361, M170908362, M170908363, M170908364, M170908365, M170908366, M170908368, M170908369, M170908370, M170908371, M170908372, M170908373, M170908374, M170908375, M170908378, M170908379, M170908380, M170908381, M170908382, M170908383, M170908384, M170908386, M170908387 and 475 more |
| Model numbers | CM1100, CM3000 |
Product
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Reason for recall
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
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-2522-2018. 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.