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.
“Oscor Abiomed Introducer Kit Recall: Potential Leaks in 14F Sheaths.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49020-oscor-abiomed-introducer-kit-recall-potential-leaks-in-14f-sheaths. Based on FDA recall #Z-2678-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2678-2026%22&limit=1).
The FDA announced on June 10, 2026, that Oscor Inc. is recalling the Abiomed Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F due to potential sheath leakage. The recall affects 355 units distributed in Massachusetts.
How to tell if you have it
Abiomed REF: 0052-3025
Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
UPC 00813502010664
UPC 00885672009793
The hazard
According to the FDA, manufacturing issues may cause 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.
Context
GovInfoNow's records show Oscor Inc. has three other recalls on record since September 26, 2018. Other recent recalls of similar products include Abiomed Impella CP Introducer Kit Recall (June 11, 2026), Abiomed Intro Kit Recall (June 11, 2026), and Abiomed Impella CP Set Recall (June 11, 2026).
How to tell if you have this one
Check for the Abiomed Introducer Kit with model number 0052-3025. The kits have specific lot numbers: 00885672009793 or 00813502010664.
Brand
Oscor
Product
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Distribution in the US state of MA
Recall number
Product, codes & lots
Quantity
Z-2678-2026
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.; All Lots within Expiry/GTIN:00885672009793, 00813502010664
355 units
Z-2679-2026
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.; All Lots within Expiry/GTIN:00885672009786/00813502010558
1332 units
Z-2680-2026
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.; All Lots within Expiry/GTIN:00885672009755/00813502011609
32,934 units
Based on the official FDA remedy
What to do — step by step
Check Product Lot Numbers
Look for lot numbers 00885672009793 or 00813502010664 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in Massachusetts.
Listed by the agency
Not listed
FDA distribution: “Distribution in the US state of MA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2678-2026 (June 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2678-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.