⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Oscor Inc.: Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and

Medical DevicesSource: FDA (device) · Date: 2026-07-22

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for Oscor

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Oscor Inc.
Product
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Reason / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
Distribution in the US state of MA
Recall initiated
2026-06-10
Code info
All Lots within Expiry/GTIN:00885672009786/00813502010558
Product quantity
1332 units
Voluntary mandated
Voluntary: Firm initiated
City
Palm Harbor
State
FL
Country
United States
Event id
99102
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.