FDA Records Class I Recall of Abiomed Impella CP Pump Sets Over Introducer Leak Risk
An FDA enforcement report covering 87,277 units cites potential introducer sheath leakage that the record says is not visually detectable by users.
Recalls & Safety Alerts in Danvers, Massachusetts
Every recalls & safety alerts report published for Danvers, Massachusetts, newest first.
FDA classifies Abiomed Impella CP introducer kit recall as Class I
An enforcement report covering 846 units of the 14 Fr introducer kit cites a potential for sheath leakage that the record says is not visually detectable by users.
FDA Classifies Abiomed Impella CP Introducer Kit Recall as Class I
An FDA enforcement report lists 1,540 units of the 14 Fr introducer kit recalled worldwide over a potential sheath leakage issue that the record says is not visible to users.