FDASeptember 8, 2016device
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator incl...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
What to do
FDA enforcement status: Terminated
Brands named
greatbatch medicalgreatbatch
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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