Boston Scientific’s Imager II catheters are coming off the market, and the complaint data is not why. The FDA published an early alert on Friday saying no increase in tip-detachment complaints turned up for the affected lots. They are being removed because the company built them outside the approved design specification.
The Imager II is a sterile, single-use catheter that doctors thread into the peripheral vasculature to image it. Boston Scientific determined that the tips on these lots were made with reduced levels of stabilizing agents, which raises the risk that a tip degrades and comes apart. The FDA describes two outcomes. Most of the time a detached tip costs a delay while somebody exchanges the device. In the remote case a fragment lodges in a vessel, cuts off blood flow, and takes an organ with it. As of July 16 the company had reported two serious injuries and no deaths.
A gap against the spec, with no complaint behind it
Somebody compared the units coming off the line against the specification on file and found a gap. Under the rules, that gap is grounds for removal by itself, with no complaint signal required.
A design specification is the description of the device the agency reviewed, and what it reviewed included how the device gets made. A manufacturer building to a different specification is outside its own clearance whether or not a patient ever notices. The product can be performing acceptably in every hospital that uses it, and the removal still happens.
Getting the catheters back out of the hospitals
Boston Scientific’s letter went to customers on August 24, and most of the FDA notice is retrieval logistics: stop using the product, segregate it, fill in a tracking form, send the catheters back. The notice then warns that hospitals often discard the outer carton and shelve the catheters in the inner pouch, and that the code printed on the inner pouch is a different number from the one on the box. The tracking form carries only the outer codes. The catheters ship in five-packs, and returns have to be counted as individual units.
So the person standing in a supply room with that form has to match a pouch in their hand against a number that was never printed on it. Nothing about that is a manufacturing failure. It is a labeling decision, made years earlier by people solving a different problem.
The version of this I lived through was in software. When Apple changed the Mac file system and deprecated the old primitives, my company found more than 2,800 separate instances of file open and save calls in our own codebase. They were not consistent enough for a search and replace. One engineer, Jim Bates, spent about six months cataloging every variation and then updating every one of them. Companies that were less thorough shipped breakage the day the old calls stopped working.
The line is being discontinued anyway
Boston Scientific has also decided to stop selling the Imager II. The retrieval happens regardless, and every unit already sitting in a hospital supply room still has to be accounted for.
The alert does not explain how the stabilizing agents ended up low, and I have no idea what happened inside that plant. I do know what a product on its way out looks like from the inside. The strongest engineers are on the next platform. A supplier change gets a lighter review than it would have gotten three years earlier. The process running the line has not had a hard look in a while, and the line is still shipping.
If you build anything in lots (devices, diagnostic assays, defense hardware, battery packs), the specification question is cheap to answer now and expensive later. For every lot you have shipped, can you name the specification it was built to?
Can somebody holding one of your units in a stockroom tell you which lot it came from? That is the question I would go ask today, because it is the one nobody can answer in the moment. The answer was settled long ago, probably in a packaging meeting nobody remembers.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →