FDA issues warning over use of Boston Scientific stents after 167 injuries, 3 deaths
The U.S. Food and Drug Administration (FDA) said it’s aware of a recall on stents manufactured by Boston Scientific, as the company sent a letter to customers in December 2025 recommending that some of its products be removed from where they are used or sold.
The FDA is spreading awareness by sending out an early alert of its own, in which the agency calls the recall a “potentially high-risk device issue.” According to Boston Scientific, providers have had issues deploying AXIOS Stents and Electrocautery Enhanced Delivery Systems. In some instances, the devices will not expand as designed, and could require surgical intervention to remove.
The AXIOS stent is placed inside the abdomen, connecting the stomach or intestine to another internal organ, typically done through an endoscope passed through the mouth. This is done to facilitate endoscopic drainage of fluid around the pancreas or gallbladder.
Because of the risk of causing severe injury to a patient's internal organs, as this recall progresses, it’s likely to earn the FDA’s most serious Class I designation. As of December 23, 2025, Boston Scientific reports 167 injuries and three deaths associated with the malfunctioning stents, exemplifying how crucial it is to remove them from clinical settings.
What is being recalled?
Device Name | UDI | UPN |
AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729904540 | M00553520 |
AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729904557 | M00553530 |
AXIOS Stent and Electrocautery Enhanced Delivery System | 08714729951100 | M00553560 |
AXIOS Stent and Electrocautery Enhanced Delivery System | M00553660 | |
AXIOS Stent and Electrocautery Enhanced Delivery System | M00553680 | |
AXIOS Stent and Electrocautery Enhanced Delivery System | M00553690 |
Next steps
Any stents and delivery systems subject to the recall should be quarantined and returned to Boston Scientific. However, if any of the devices are already implanted inside a patient, the company recommends following normal standards of care. Based on current reports, the dangerous issue only occurs while the stent is being deployed.
As a precaution, the company said a copy of the recall notice should be placed near supplies to ensure all impacted products are identified and isolated. Anyone who has distributed AXIOS stents to another facility should contact the recipient to alert them to the potential dangers.
Anyone aware of any additional adverse events associated with the faulty stents should contact Boston Scientific at [email protected].
The company said its letter sent to customers on December 19, 2025, contains instructions on how to return the stents for a replacement.
As this is an evolving situation, the FDA said it will provide updates as new developments arise. The agency’s notice can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.