Summary
The FDA issued a Class I for Impella RP with SmartAssist. Product Code: 0046-0035. by Abiomed, Inc.. Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift..
Details
Source
Device Recall
External ID
Z-1469-2026
Action Date
2026-03-11
Status
Ongoing
Category
device
Product Description
Impella RP with SmartAssist. Product Code: 0046-0035.
Lot/Code Info: Product Code: 0046-0035. UDI-DI: 00813502011869.
Quantity Affected: 291 units
Reason for Recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-27
Company
Danvers, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 133 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-1469-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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