Recall record at a glance
| Official record | Z-0636-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Abiomed, Inc. |
| Report date | Jan 10, 2024 |
| Recall initiation date | Dec 6, 2023 |
| Quantity | n/a - no physical product |
| Location | Danvers, MA, United States |
Official product description
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Why the product was recalled
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
Distribution information
Domestic distribution nationwide.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.