Seeker® SK13518Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741067884), received between Jul 29, 2021 and Aug 28, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  On (b)(6) 2026, prior to a recanalization procedure using a Seeker catheter, the patient presented with ASO in the left lower limb. A V18 guidewire was selected for recanalization, and a Seeker stylet was used in conjunction with it. Upon deployment of the Seeker catheter, a crease was observed on the distal portion of the catheter, preventing the V18 guidewire from passing through the distal tip. As a result, recanalization of the lesion could not be performed with the device. The guidewire was unable to pass through the distal tip. The procedure was completed using another device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492798 ↗
• MalfunctionSep 26, 2025Device Contamination with Chemical or Other Material; Device Handling Problem; Device Contamination with Chemical or Other Material; Device Handling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE SEEKER CATHETER. DURING THE PROCEDURE, THE DOCTOR ACCIDENTALLY DROPPED THE CATHETER AND MADE IT UNCLEAN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23152188 ↗
• MalfunctionAug 28, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  ON (B)(6) 2025, A PATIENT PREPPED FOR A RECANALIZATION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE SEEKER CATHETER ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910751 ↗
• InjuryApr 7, 2025Detachment 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 HEAD END OF THE SUPPORT CATHETER WAS ALLEGEDLY FOUND TO HAVE A SPLIT. IT WAS FURTHER REPORTED THAT IT WAS CONFIRMED AFTER THE EXIT OF THE SUPPORT CATHETER THAT THE HEAD END HAD BEEN SPLIT. REPORTEDLY, THE SEPARATED PART WAS REMOVED BY CUTTING THE BLOOD VESSEL OPEN IN AN OPERATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT IS REPORTED TO BE DOING WELL.

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

  MAUDE report 21783611 ↗
• InjuryApr 7, 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 HEAD END OF THE SUPPORT CATHETER WAS ALLEGEDLY FRACTURED IN THE BLOOD VESSEL. IT WAS FURTHER REPORTED THAT THE HEAD END WAS LEFT INSIDE THE SUPERFICIAL FEMORAL ARTERY VESSELS. REPORTEDLY, THE ARTERY VESSELS WERE FINALLY INCISED TO TAKE OUT THE HEAD END OF THE RESIDUAL SUPPORT CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. HOWEVER, THE CURRENT STATUS OF THE PATIENT UNKNOWN.

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

  MAUDE report 21782964 ↗
• MalfunctionJan 5, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, IT WAS DISCOVERED THAT THE POSITION OR THE LENGTH OF THE CATHETER MARKER SEEMED TO BE DIFFERENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173601 ↗
• MalfunctionJul 29, 2021Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SUPPORT CATHETER WAS ALLEGEDLY DETACHED AND UNABLE TO CROSS LESION. REPORTEDLY, ANOTHER SUPPORT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12244457 ↗