Seeker® SK9018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741067945), received between Apr 15, 2020 and Jun 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Flushing Problem; Device-Device Incompatibility; Material Twisted/Bent; Break; Flushing Problem; Device-Device Incompatibility; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE SEEKER SUPPORT CATHETER. PRIOR TO THE PROCEDURE, IT WAS FELT MORE RESISTANCE WHEN PERFORMING THE FLASH OUTSIDE THE BODY. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE GOT CAUGHT ON THE CATHETER TIP. REPORTEDLY, THE CATHETER WAS SLIGHTLY BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122040 ↗
• MalfunctionDec 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE HIGHLY CALCIFIED LESION, THE TIP OF THE DEVICE WAS ALLEGEDLY WHITTLED BY THE CALCIFICATION, MAKING IT INOPERABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388787 ↗
• MalfunctionJun 15, 2021Detachment 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 SUPPORT CATHETER WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998531 ↗
• MalfunctionOct 27, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL SK9018 SUPPORT CATHETER ALLEGEDLY DEVICE MARKINGS/LABELLING PROBLEM. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE ONE PATIENT WITH NO PATIENT CONSEQUENCES. PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10744700 ↗
• MalfunctionApr 15, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SK9018 SUPPORT CATHETER ALLEGEDLY EXPERIENCED DEVICE-DEVICE INCOMPATIBILITY AND A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963896 ↗