Seeker® SK13535MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741067891), received between Jun 20, 2018 and Mar 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE CATHETER WAS ALLEGEDLY SEPARATED FROM HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685469 ↗
• MalfunctionJan 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE PROBE ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109540 ↗
• MalfunctionFeb 21, 2024Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DEVICE HAD ALLEGEDLY BROKEN INTO SEVERAL PIECES. REPORTEDLY, ALL THE BROKEN PIECES WERE RETRIEVED USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746373 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT DURING PREPARATION OF A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND TO BE RUPTURED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926649 ↗
• MalfunctionApr 15, 2020Break; Break

  THIS REPORT SUMMARIZES SIX MALFUNCTION'S. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SK13535M SUPPORT CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THE MALFUNCTIONS INVOLVED A PATIENT WITH NO CONSEQUENCES. ONE PATIENT WAS A (B)(6) MALE. THE REMAINING PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963751 ↗
• MalfunctionJun 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TREATMENT OF A HIGHLY CALCIFIED LESION IN SFA, THE RECANALIZATION CROSSING SUPPORT CATHETER ALLEGEDLY BROKE IN SEGMENTS. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO CAPTURE AND RETRIEVE ALL THE SEGMENTS. REPORTEDLY, THERE WAS NO FURTHER TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7621390 ↗