NA STJ408310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551044929), received between May 16, 2017 and Sep 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K152090); they may or may not involve this specific model.

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.

Recalls naming this device

1. Sep 17, 2018Terminated

   Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

   Z-0090-2019 · Root cause: Material/Component Contamination · Recall details · 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.

• MalfunctionSep 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED ST JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER, BI-DIRECTIONAL, MEDIUM CURL-22 AND THE FLUSHING SIDE PORT OF THE SHEATH BROKE OFF. THE SIDE PORT BROKE OFF JUST BEFORE GOING INTO THE PATIENT¿S BODY, THEREFORE THE ONLY PORTION OF THE DEVICE USED ON THE PATIENT WAS THE WIRE. THERE WAS NO DIFFICULTY NOTED PRIOR TO BREAK AND THERE WERE NO CIRCUMSTANCES NOTED THAT CONTRIBUTED TO THE BREAK, IT IS REPORTED TO HAVE JUST POPPED OFF. THIS EVENT HAS BEEN ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516824 ↗
• MalfunctionMay 22, 2017Break; Break

  IT WAS REPORTED THAT THE HUB ASSEMBLY CAME APART WHILE INSIDE PATIENT. THERE WAS NO HARM OR CONSEQUENCE TO THE PATIENT. NO DEVICE WILL BE RETURNED, IT WAS ACCIDENTALLY DISCARDED BY THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6581264 ↗
• MalfunctionMay 16, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE VALVE CAP BROKE OFF WHILE IN USE. PHOTOS REVEAL NO PART LEFT INSIDE PATIENT. NO HARM OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6570858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152090. One submission often covers many models, so check the product and lot details in each record.

• Z-0213-2018 · Jun 2, 2017 · Terminated
  St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed