Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote
Summary
The FDA issued a Class II for Impella Connect, software portal for online device management that allows clinic by Abiomed, Inc.. Reason: The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: .
Details
Source
Device Recall
External ID
Z-0636-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Lot/Code Info: UDI-DI 00813502011647 Software version 1.1 - 3.17.1
Quantity Affected: n/a - no physical product
Reason for Recall
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
Domestic distribution nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-06
Company
Danvers, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 84 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0636-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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