Seeker® SK15018Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741067914), received between Oct 25, 2018 and Sep 2, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Detachment of Device or Device Component

  On (b)(6) 2026, a patient underwent a recanalization procedure using a Seeker Support Catheter via femoral access. During the procedure, it was reported that the catheter ruptured while being advanced over a 0.018-inch guidewire. The catheter separated into two pieces. The procedure was subsequently completed using a competitor's catheter. No patient harm was reported, and there was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559113 ↗
• MalfunctionJul 27, 2026Detachment of Device or Device Component

  On (b)(6)2026, a patient underwent a recanalization procedure using the Seeker catheter. During the procedure, the catheter was allegedly found fractured. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50032306 ↗
• MalfunctionFeb 17, 2026Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING SEEKER. DURING THE PROCEDURE, THE SEEKER CATHETER WAS ALLEGEDLY UNABLE TO REMOVE AND NEEDED TO REMOVE FORCEFUL AND OBSERVED STRUCTURAL DAMAGE TO THE CATHETER WITH THE RADIOPAQUE RING. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362861 ↗
• InjuryJan 13, 2026Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE SEEKER CATHETER. DURING THE PROCEDURE, THE SEEKER ALLEGEDLY BROKEN COMPLETELY. IT WAS FURTHER REPORTED THAT THE DETACHED PIECE WAS LEFT INSIDE THE PATIENT. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 24050667 ↗
• MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE IN RIGHT COMMON FEMORAL ARTERY USING THE SEEKER. DURING THE PROCEDURE IT WAS REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY UNABLE TO PASS THROUGH THE OCCLUDED LESION. IT WAS FURTHER REPORTED THAT THE HEAD END OF THE SUPPORT CATHETER BROKE, DURING THE OPENING PROCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931079 ↗
• MalfunctionJul 2, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE SEEKER CATHETER. PRIOR TO THE PROCEDURE, THE SUPPORT CATHETER SEEKER WAS ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380747 ↗
• MalfunctionApr 4, 2025Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY STUCK AND COULD NOT BE REMOVED WHEN OUTER PACKAGE WAS OPENED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS BROKEN AND DETACHED BY APPLYING A LITTLE FORCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774842 ↗
• InjuryMar 11, 2025Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SUPPORT CATHETER WAS ALLEGEDLY DISCONNECTED DURING WITHDRAWAL. IT WAS FURTHER REPORTED THAT THE CATHETER WAS BROKEN AND LAGGING IN THE ARTERY. REPORTEDLY, THE ANTERIOR TIBIAL ARTERY WAS NARROWED, SO THE INTERVENTIONAL DEVICE COULD NOT PASS THROUGH, AND IT COULD ONLY BE REMOVED SURGICALLY, AND THE OPERATION WAS TERMINATED AFTER OPENING THE POSTERIOR TIBIAL AND PERONEAL ARTERIES. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21570056 ↗
• MalfunctionNov 22, 2024Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY OF THE LOWER LIMB, THE CATHETER WAS ALLEGEDLY JAMMED DURING ADVANCEMENT. IT WAS FURTHER REPORTED THAT A SNAG OCCURS THE CATHETER CANNOT BE ALLEGEDLY WITHDRAWN SMOOTHLY ALONG THE GUIDEWIRE. REPORTEDLY, THE GUIDEWIRE AND CATHETER WERE WITHDRAWN FROM THE BODY, AND THE BROKEN PART WAS WITHDRAWN TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755301 ↗
• MalfunctionOct 19, 2024Material Separation; Stretched; Detachment of Device or Device Component; Material Separation; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE CATHETER HAS BEEN ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE CONE HEAD FALLS OFF AND SEPARATES FROM THE CATHETER. FURTHERMORE, THE CONE HEAD STILL CONNECTED TO THE CORE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488942 ↗
• MalfunctionSep 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE IN THE LOWER LIMB ARTERY OPENING, THE SUPPORT CATHETER WAS REMOVED FROM THE PROTECTIVE SLEEVE AND THE TIP WAS ALLEGEDLY FOUND TO BE FULLY SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115796 ↗
• MalfunctionJun 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE OCCLUDED LOWER LIMB ARTERY, THE CATHETER ALLEGEDLY BROKE DURING THE FLUSHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636875 ↗
• MalfunctionFeb 15, 2024Break; Material Puncture/Hole; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Material Puncture/Hole; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN RIGHT FEMORAL ARTERY, THE GUIDEWIRE ALLEGEDLY FAILED TO PASS THROUGH THE SUPPORT CATHETER. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY POKED OUT AT THE HALF-SECTION OF THE SUPPORT CATHETER. REPORTEDLY, THE SUPPORT CATHETER WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708711 ↗
• MalfunctionSep 27, 2023Break; Difficult to Open or Remove Packaging Material; Material Deformation; Break; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY COULD NOT BE REMOVED FROM THE PROTECTOR. IT WAS FURTHER REPORTED THAT AFTER REMOVAL, THE CATHETER WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824731 ↗
• MalfunctionMay 30, 2023Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR A RECANALIZATION PROCEDURE, RED SLIM SUBSTANCE WAS ALLEGEDLY NOTICED AS IT WAS REMOVED FROM THE LOOP. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017780 ↗
• MalfunctionDec 16, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, CATHETER ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT RUPTURED CATHETER TIP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993801 ↗
• MalfunctionFeb 10, 2022Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS STUCK INSIDE THE SHEATH AND THERE WAS DIFFICULTY REMOVING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13504016 ↗
• MalfunctionSep 8, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED AND THE BOXES ARE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437543 ↗
• MalfunctionSep 8, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT DURING TRANSPORTATION, IT WAS FOUND THAT THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437538 ↗
• MalfunctionSep 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT DURING TRANSPORTATION, IT WAS FOUND THAT THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434743 ↗
• MalfunctionSep 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT DURING TRANSPORTATION, IT WAS FOUND THAT THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431932 ↗
• MalfunctionSep 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT DURING TRANSPORTATION, IT WAS FOUND THAT THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431883 ↗
• MalfunctionSep 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT DURING TRANSPORTATION, IT WAS FOUND THAT THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431877 ↗
• MalfunctionSep 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT, THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431875 ↗
• MalfunctionSep 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT DURING TRANSPORTATION, IT WAS FOUND THAT THE PRODUCTS WERE NOT PACKED IN BOXES WHICH CAUSED THE BOXES TO BE DENTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431783 ↗