Dive Brief:
- Intuitive Surgical has recalled stapler reload cartridges after receiving reports of four serious injuries and one death.
- The Food and Drug Administration communicated the recall in an early alert Wednesday, one week after Intuitive asked customers to quarantine and return all affected and unused reloads.
- An Intuitive spokesperson said in an email to MedTech Dive that the company is still investigating the root cause of rare reports of incomplete staple lines when using the recalled 8 mm SureForm gray reload cartridges.
Dive Insight:
The FDA granted 510(k) clearance to Intuitive’s 8 mm SureForm 30 curved-tip stapler and three types of staple reloads in 2021. Physicians use the stapler with da Vinci surgical robots. The staples in the three types of reloads have different lengths, with the 2 mm staples in the gray cartridges designed for extra-thin tissue.
Intuitive has asked customers who ordered 8 mm SureForm 30 gray stapler reloads on or before Feb. 20 to return the devices. The company spokesperson said suitable alternatives are available, which should enable surgeons to continue to perform procedures with minimal disruption.
The recall follows reports of incomplete staple lines that were correlated to surgical bleeding events. The company reported incomplete staple lines after the da Vinci system returned a completed stapler fire with gray reloads on blood vessels. If that happens, the FDA said the patient could bleed and physicians may need to switch from robotic to open surgery.
In December, Intuitive received a report of a patient dying during a surgery using the 8 mm SureForm gray stapler reload. Intuitive received four other reports of incomplete staple lines correlated to surgical bleeding events from January 2024 to January 2026. All the events happened during the procedure.
While the FDA said Intuitive recommended curved-tip staplers be removed from use, the spokesperson clarified that the recall only applies to the 8 mm SureForm 30 gray reloads. Surgeons can continue to use the stapler with blue and white reloads, according to the statement.
SureForm 30 is authorized in general, thoracic, gynecologic, urologic and pediatric surgery. Intuitive has said the device may be particularly well suited to thoracic procedures and appendectomies.
