Seeker® SK13514Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741067877), received between Jul 11, 2019 and Sep 2, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Peeled/Delaminated; Device-Device Incompatibility

  On (b)(6) 2026, a patient underwent a recanalization procedure using a Seeker Crossing Support Catheter for the treatment of a calcified superficial femoral artery (SFA) lesion via a contralateral approach. During the procedure, it was reported that the guidewire could not be advanced through the distal tip of the catheter. After multiple attempts, the guidewire was successfully advanced; however, difficulty was subsequently encountered during withdrawal of the guidewire through the distal tip. Upon removal, flaking of the guidewire's polymer coating was observed. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559365 ↗
• MalfunctionApr 8, 2024Retraction Problem; Failure to Advance; Material Deformation; Retraction Problem; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE CONTRALATERAL APPROACH, BECAUSE THE BIFURCATION ANGLE WAS TOO TIGHT, THE CATHETER HAD ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY COULD NOT ABLE TO CROSS THE LESION. FURTHERMORE, THE DEVICE ALLEGEDLY HAD RETRACTION PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057609 ↗
• MalfunctionJan 23, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SUPPORT CATHETER ALLEGEDLY TORN OFF IN A SECTION OF THE CENTIMETER TIP WITHOUT BEING ABLE TO REACH THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565644 ↗
• MalfunctionDec 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE DEVICE WAS ALLEGEDLY WRENCHED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333990 ↗
• MalfunctionJan 6, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE PHYSICIAN ALLEGEDLY NOTED THAT THE POSITION OR THE LENGTH OF THE MARKER SEEMED TO BE DIFFERENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173902 ↗
• MalfunctionJul 11, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SK13514 SEEKER CROSSING SUPPORT CATHETER ALLEGEDLY EXPERIENCED A BREAK AND TIP DETACHMENT. THIS INFORMATION WAS RECEIVED FROM * ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8783027 ↗