OFFICIAL-SOURCE RECALL · UNITED STATES
Catheter Introducer Correction: Abiomed and Oscor Correction for Recall: Abiomed and Oscor have identified a
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryUnited StatesPublishedAugust 10, 2026Last updatedAugust 10, 2026Official source last checkedAugust 24, 2026 at 2:53 PM UTC
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Hazard
Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
Official recall notice
Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
Agency: FDA MedWatch
Official publication date: August 10, 2026
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