Recalling a Recall

My boy Gee developed hydrocephalus following his birth. Hydrocephalus, or water on the brain, is a very common condition (up to 80%) in children with spina bifida. (The spinal injury actually pulls the cerebellum down toward the neck, blocking the easy flow of spinal fluid, which leads to the buildup of the fluid in the brain.) The treatment for hydrocephalus, regardless of cause, is the insertion of a shunt, which is basically a long tube running from the brain into the abdominal cavity. The shunt drains the excess fluid, thus protecting the brain from injury from fluid pressure.

Gee's shunt was inserted when he was three weeks old. The procedure is, quite literally, brain surgery--and yet it only merited an overnight stay at the hospital. (Isn't medical science amazing?) Shunts, as a mechanical medical device, can (and will) fail due to blockage (20-30% fail in the first year of placement); Gee, however, hasn't had a day of trouble since his shunt surgery almost three years ago. (This good track record isn't really an indication of the possibility of future failure. All shunts will eventually have to be replaced, and so Gee can expect several shunt replacements in his life.)

So, consider: There is a life-saving medical device inserted in your child's brain. What is the last thing you would like to hear from the hospital?

Dear Parent/Patient:

We are writing to inform you about your child's ventriculoperitoneal shunt...Recently we have seen seven instances where the shunt tube in the brain (ventricular catheter) has become disconnected from the rest of the shunt. We have only seen this with a ventricular catheter called BioGlide.

The manufacturer of BioGlide, Medtronic, has recently issued a voluntary recall of all [unused] BioGlide ventricular catheters...The company is not recommending any action in situations where the BioGlide ventricular catheter is currently in use by a patient.

According to our records your child has a Medtronic BioGlide ventricular catheter in place...We are not recommending that these ventricular catheters be removed or changed. If you have concerns, however, we would be happy to arrange for a CT scan to check the shunt and the ventricles, without a cost to you...

Poor Primary Children's Hospital! Can you imagine learning that the device you have inserted into (probably) hundreds of children's brains is being recalled? I'd be a little ticked off, if I were the pediatric neurosurgeons, if only because the frustrations of the parents are going to land on them, not on Medtronic.

To be honest, I'm not at all fussed about this event. (And, by the way, we received this letter in March. I'm only writing about it because I just came across the packet they sent along as I was cleaning out some files.) We know that Gee's shunt will fail eventually. We know that the risk of infection in a shunt surgery is higher than the risk of the BioGlide failing. We didn't even go get a CT scan on the hospital's dime (or would it be Medtronic's dime?), because Gee just had a checkup scan in December.

Still, with all the discussion of recalls of everything from toys to spinach, it's a little disconcerting to have the medical device inserted in your child's brain being the subject of a recall.