Seeker® SK6535MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741067938), received between May 18, 2017 and Jun 27, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622052 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE HIGHLY CALCIFIED ARTERY, THE DEVICE WAS ALLEGEDLY SECTIONED DURING OPERATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571313 ↗
• InjuryMar 14, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD DIFFICULTIES IN ADVANCEMENT AND REMOVAL ISSUE. IT WAS FURTHER REPORTED THAT THE END OF THE DEVICE DETACHED AND MIGRATED INTO THE ARTERY. THE DETACHED END WAS REMOVED BY UNDERGOING CONVENTIONAL SURGERY THROUGH COMMON FEMORAL TO RECOVER THE EXTREMITY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13754837 ↗
• MalfunctionMay 18, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON REMOVAL OF THE SUPPORT CATHETER FROM THE DEVICE PACKAGING, APPROXIMATELY 5CM OF THE TIP OF THE CATHETER WAS ALLEGEDLY DETACHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6577265 ↗