FDA Records Class I Recall of 355 Abiomed Impella Introducer Kits Over Potential Sheath Leaks
An FDA enforcement report lists an ongoing Class I recall by Oscor Inc. of an Impella introducer kit distributed in Massachusetts, initiated June 10, 2026.
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An FDA enforcement report lists an ongoing Class I recall by Oscor Inc. of an Impella introducer kit distributed in Massachusetts, initiated June 10, 2026.