Here comes the recall

Quote


















Everyone may say this is no big deal but quietly at Lake Oswego there is a lot of nervousness and panic. The mantra of no lead recall ever will be challenged and put away. As will this blip on the radar screen of device companies.
 


















Anonymous said:
Everyone may say this is no big deal but quietly at Lake Oswego there is a lot of nervousness and panic. The mantra of no lead recall ever will be challenged and put away. As will this blip on the radar screen of device companies.
Click to expand...

The "no lead recalls" message never got me anything but the following response: "You mean: no lead recalls, yet."

I don't see this growing into a Class I, but the good news is....having spent some time with the Big 3...I am well-prepared for handling one.
 






Anonymous said:
The "no lead recalls" message never got me anything but the following response: "You mean: no lead recalls, yet."

I don't see this growing into a Class I, but the good news is....having spent some time with the Big 3...I am well-prepared for handling one.
Click to expand...

I absolutely agree with 'yet'. Hopefully, not but CRM history shows that it is not IF but WHEN.

That being said, one reported case or even two reported cases in abstracts (questionable abstracts at that) does not even make the FDA blink. Look at what it took for them to act on Riata, Fidellis and now the Durata saga doesn't seem to be going away either.
 












Anonymous said:
Oh you two sound like some St jude reps I know. They said the same things. But in 2009 & 10
Click to expand...

So, from this comment I can say that you [being a Boston or MDT Rep] could ask your colleagues who were around during Prizm or Fidelis if this is how they sounded?

What you fail to acknowledge is that both of us readily accept that a recall may be in Biotronik's future...an atypical response on CP given the fact that blindly promoting one's brand is the standard.

Quality stopped being the motivating factor behind an implanter's decision to use a product years ago...if you don't believe me...then explain how anyone could be implanting anything the Big 3 makes?

No...the turmoil of the past 10 years has forced the implanters to accept the legions of reps telling them that recalls are just "part of the business". And so - they shrug their shoulders and hope for the best.

So - yes - maybe Biotronik will have a recall at some point, thankfully the sins of the Big 3 have mitigated the impact of that prospect.
 


















Top Bottom
Back
Quote