Seeker® SK15014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741067907), received between Jan 29, 2018 and Jun 11, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 16, 2018Terminated

   Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

   Z-1803-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2025, A 86-YEAR-OLD MALE PATIENT UNDERWENT A SEEKER PROCEDURE. DURING THE PROCEDURE, THE CATHETER HUB FULLY SEPARATED OUTSIDE THE BODY AND STILL ON WIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182065 ↗
• InjuryApr 12, 2021Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT WHILE PULLING THE CATHETER OVER THE WIRE WHICH WERE IN A STENOSED AND FULLY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA), RESISTANCE WAS SUDDENLY GONE AND THE PROXIMAL PART OF THE CATHETER WAS ALLEGEDLY FOUND TO BE TORN INSIDE THE ATA. THE DEVICE WAS NOT RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647821 ↗
• MalfunctionJan 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING REMOVAL OF THE SUPPORT CATHETER FROM THE PATIENT, THE CATHETER ALLEGEDLY DETACHED INTO SEVERAL SEGMENTS. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO CAPTURE AND RETRIEVE ALL BUT ONE OF THE DETACHED SEGMENTS. THERE WAS NO PLAN TO RETRIEVE THE DETACHED SEGMENT. PATIENT WAS REPORTED AS ASYMPTOMATIC.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7226758 ↗