Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F,
Summary
The FDA issued a Class I for Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introd by Oscor Inc.. Reason: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along t.
Details
Source
Device Recall
External ID
Z-2679-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Lot/Code Info: All Lots within Expiry/GTIN:00885672009786/00813502010558
Quantity Affected: 1332 units
Reason for Recall
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Distribution
Distribution in the US state of MA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-10
Company
Palm Harbor, FL
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.
Oscor Inc. has 4 FDA actions in our database, including 4 recalls.
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 (Oscor Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oscor Inc. have FDA actions?
Oscor Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2679-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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