ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-300
Summary
The FDA issued a Class I for ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; con by Abiomed, Inc.. Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manu.
Details
Source
Device Recall
External ID
Z-2688-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Lot/Code Info: Pump Set Codes 1000459, 1000460; Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field.
Quantity Affected: 1,574 units
Reason for Recall
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Distribution
Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-11
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 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Abiomed, Inc. has 83 FDA actions in our database, including 78 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 83 FDA actions in our database, including 78 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2688-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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