Reported Aug 1, 2018 · Terminated
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital…
Abbott Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories, Inc. · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424
Is this the product you have?
- CardioMEMS HF System
- Hospital and Patient Electronics Units
(a) Patient Electronics SystemModel CM1100 (b) Hospital Electronics SystemModel CM3000
- Lot codes and dates
- (a) Patient Electronics System, Model CM1100
- UDI 05414734509800 Serial Numbers(b) Hospital Electronics System, Model CM3000
2,394 of 2,394 codes
P170102263P170102267P170202710P170604856P170704970P170805650P170805651P170805652P170805653P170805654P170805655P170805656P170805657P170805658P170805659P170805660P170805661P170805662P170805663P170805664P170805665P170805666P170805667P170805668P170805669P170805670P170805671P170805672P170805673P170805674P170805675P170805676P170805677P170805679P170805681P170805682P170805683P170805684P170805685P170805687P170805688P170805689P170805690P170805691P170805692P170805693P170805694P170805695P170805696P170805697P170805698P170805700P170805701P170805702P170805703P170805704P170805705P170805706P170805707P170805708
- UDI 05415067029331 Serial Numbers
127 of 127 codes
M170908359M170908360M170908361M170908362M170908363M170908364M170908366M170908368M170908369M170908370M170908371M170908372M170908373M170908374M170908375M170908378M170908379M170908380M170908381M170908383M170908384M170908386M170908387M170908389M170908390M170908391M170908392M170908394M170908395M170908396M171108397M171108398M171108399M171108402M171108403M171108404M171108405M171108408M171108409M171108412M171108414M171108415M171108416M171108417M171108419M171108420M171108422M171108423M171108424M171108426M171108427M171108429M171108430M171108431M171108432M171108433M171108436M171108437M171108438M171108439
- Amount recalled
- 2521 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Abbott Laboratories, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.