Seeker® SK9035MRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741067952), received between Mar 29, 2018 and Jun 3, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Detachment of Device or Device Component; Material Deformation

  On (b)(6) 2026, a patient underwent a recanalization procedure using a Seeker catheter. During the procedure, the tip of the catheter split and separated into two pieces, with a portion becoming lodged in the patient. Furthermore, open surgery was performed to remove the part of the catheter that broke off in the patient. The current status of the patient is unknown.

  Patient problems: Foreign Body In Patient

  MAUDE report 25369967 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA A CONTRALATERAL APPROACH, THE SUPPORT CATHETER ALLEGEDLY KINKED WHEN THE DEFLECTION WAS ATTEMPTED TO BE STRETCHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031945 ↗
• MalfunctionMar 4, 2023Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE LAST FOUR INCHES OF THE CATHETER BETWEEN THE MARKERS ALLEGEDLY SEPARATED AFTER REMOVING IT FROM THE PLASTIC HOOP TO FLUSH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483410 ↗
• MalfunctionFeb 10, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE BROKE INSIDE THE PATIENT. REPORTEDLY THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13504641 ↗
• MalfunctionDec 9, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN IN ITS PROTECTIVE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966230 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081955 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT PRIOR TO THE TRANS LUMINAL ANGIOPLASTY PROCEDURE, THE DEVICE CATHETER PART WAS ALLEGEDLY MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869105 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED THAT PRIOR TO THE TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY HAD A BREAK ON THE DISTAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861600 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN INTO TWO PARTS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10770245 ↗
• MalfunctionJan 16, 2020Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL SK9035M SUPPORT CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WAS NO PATIENT CONTACT. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9597439 ↗
• MalfunctionMar 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 TWO SEGMENTS. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384010 ↗