Abbott Recalls CardioMEMS Electronics Units Due to False Error Messages
Abbott is recalling 2,521 CardioMEMS Patient and Hospital Electronics Units because they may display a false Error 5 message due to a configuration defect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a false error message caused by a configuration issue without reporting any injuries, hospitalizations, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where no harm is reported.
Plain-English summary
Abbott Laboratories, Inc. is recalling 2,521 units of the CardioMEMS HF System Hospital and Patient Electronics Units. The affected products include the Patient Electronics System (Model CM1100) and the Hospital Electronics System (Model CM3000). These units were distributed in the US, Canada, the Netherlands, Germany, Great Britain, France, Ireland, and Belgium.
The recall is being issued because a small number of these electronics units may deliver a system error known as Error 5. While this error message is intended to appear when the electronics system exceeds a certain temperature, the affected units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
Customers should contact Abbott Laboratories for instructions on how to resolve the issue. The recall number is Z-2522-2018.
The recalled product
- Product
- CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
- Manufacturer
- Abbott Laboratories, Inc.
- Affected units
- 2,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- (a) Patient Electronics System
- Model CM1100
- Model CM3000
Distribution
Distribution scope not specified by the agency.
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