Seeker® SK15035MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741067921), received between Feb 28, 2018 and Oct 31, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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-1802-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2023Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, APPROXIMATELY FOUR CENTIMETERS OF THE TIP OF THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN OFF UPON REMOVAL OF THE CATHETER. REPORTEDLY, A SNARE WAS USED TO REMOVE THE BROKEN SEGMENT THROUGH THE SAME ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18043944 ↗
• MalfunctionNov 10, 2022Detachment 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 DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769091 ↗
• MalfunctionJul 16, 2020Break; Difficult to Remove; Break; Difficult to Remove

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL SK15035M SUPPORT CATHETER ALLEGEDLY EXPERIENCED BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285603 ↗
• MalfunctionApr 15, 2020Break; Break

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE MALFUNCTIONS INDICATED THAT MODEL SK15035M SUPPORT CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ONE OF THE MALFUNCTIONS INVOLVED A FEMALE PATIENT WITH NO REPORTED CONSEQUENCES. NO OTHER PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963907 ↗
• MalfunctionJan 15, 2020Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL SK15035M SUPPORT CATHETER ALLEGEDLY HAD A BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE. WEIGHT WAS NOT PROVIDED FOR THE REPORTED PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591626 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE RIGHT SFA WITH LEFT COMMON FEMORAL ARTERY ACCESS VIA A CONTRALATERAL APPROACH, THE TIP OF THE SUPPORT CATHETER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE HEALTHCARE PROVIDER (HCP) RETRIEVED THE DETACHED SEGMENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087211 ↗
• MalfunctionJun 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TREATMENT OF A HIGHLY CALCIFIED LESION IN SFA, THE RECANALIZATION CROSSING SUPPORT CATHETER WAS ALLEGEDLY BROKE IN SEGMENTS. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO CAPTURE AND RETRIEVE ALL THE DETACHED SEGMENTS. REPORTEDLY, A DABR LASER AND A BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7603995 ↗
• MalfunctionMar 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A HEAVILY CALCIFIED LESION IN THE RIGHT SFA THE TIP OF THE SUPPORT CATHETER ALLEGEDLY DETACHED AND MIGRATED TO THE PROFUNDA FEMORIS ARTERY. THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO SNARE THE DETACHED TIP BUT WAS UNSUCCESSFUL. IT WAS FURTHER REPORTED THAT THE HCP DECIDED TO LEAVE THE DETACHED TIP IN SITU AS THERE WAS NO POTENTIAL HEALTH HAZARD TO THE PATIENT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356162 ↗
• MalfunctionFeb 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TREATMENT FOR A LESION IN THE SFA, THE DISTAL TIP OF THE SUPPORT CATHETER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT AFTER MULTIPLE ATTEMPTS, THE HEALTH CARE PROVIDER (HCP) RETRIEVED THE DETACHED SEGMENT WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304576 ↗