The manufacturer has not yet reported a final root cause; the investigation is still open. The FDA lists 1,121 recalls with this root cause since 2025, 180 of them Class I (most serious). Most recent report: Jul 8, 2026.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Due to catheter separation
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of…
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.