Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product C
Summary
The FDA issued a Class I for Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro by Abiomed, Inc.. Reason: Potential for thrombus formation during prolonged use of the introducer..
Details
Source
Device Recall
External ID
Z-2600-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Lot/Code Info: Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
Quantity Affected: 17 units
Reason for Recall
Potential for thrombus formation during prolonged use of the introducer.
Distribution
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-22
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 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.
Abiomed, Inc. has 70 FDA actions in our database, including 65 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 70 FDA actions in our database, including 65 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2600-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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