The Recall After the Box Is Gone

FDA has classified Boston Scientific's removal of Imager II Angiographic Catheters as a Class I recall, its most serious category. A manufacturing problem may allow the catheter tip to degrade and detach inside the vasculature. Boston Scientific has also decided to discontinue the product.

For vascular and interventional teams, this is both an immediate inventory action and a longer-term product transition. It also exposes a familiar traceability problem: the outer box may be gone long before a recall reaches the facility.

What prompted the recall

Boston Scientific reported that affected catheter tips were manufactured with reduced levels of stabilizing agents and therefore fell outside the approved design specification. That condition may increase the risk of degradation and tip detachment.

A detached fragment can delay the procedure while the team exchanges equipment or attempts retrieval. In the most serious scenario, a fragment may obstruct blood flow, cause a life-threatening embolism and lead to organ failure.

Two serious injuries and no deaths were associated with the issue as of July 16. FDA updated the communication on September 25 to announce the Class I classification.

What facilities should do

Affected Imager II Angiographic Catheters should no longer be used or distributed. Facilities should segregate them, verify inventory against the affected product list, complete the response documentation and return recalled units to Boston Scientific.

The recall notice calls attention to an operational detail: some facilities remove catheters from the outer carton and store the sterile inner pouches on shelves. The product codes on the inner and outer packaging differ, so an inventory search based only on the code from the recall letter or outer carton may miss affected units.

Teams must compare the correct inner-pouch and outer-package identifiers and report the number of individual devices, not merely the number of multipacks.

Why discontinuation changes the response

A recall search asks, "Do we have an affected unit?" A discontinuation creates additional questions: What will replace it? Are physicians already comfortable with the substitute? Does the alternative require different accessories, storage space or setup? Must preference cards, charge records or par levels change? Does the new device alter technique or troubleshooting?

If the product is used across multiple procedural areas, each location may have different inventory and different replacement needs. Materials management, physicians, nurses, technologists, educators and supply-chain leaders should plan the transition together rather than discovering the substitution on the day of a case.

Traceability should survive repackaging

The sterile inner package is often what remains at the point of use. That package must still provide enough information for the team to determine whether a device is affected by a recall.

Facilities can strengthen traceability by preserving UDI and lot information in point-of-use storage, avoiding bins that conceal labeling, documenting lot information when required and including inner-package identifiers in recall searches. A recall process that works only while the outer carton is intact is not designed for the way products are actually stored.

The larger OR lesson

This recall is not only about one angiographic catheter. It is about whether a facility can find a product after it has been unpacked, distributed and placed near the procedure room.

Every surgical department should be able to answer three questions: Can we trace the individual device? Can we remove every affected unit before the next case? And can we transition to a substitute without creating a new patient-safety risk?

U.S. Food and Drug Administration. (Updated September 25, 2026). “Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters.” Cite for the Class I classification, the catheter-tip concern, reported injuries, affected products, removal instructions, and discontinuation.