IMAGER™ II M001314140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729736165), received between Dec 20, 2019 and May 22, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Aug 24, 2026Class IOpen, Classified

   Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

   Z-3214-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 5F IMAGER II DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER TIP BROKE WHEN THE DEVICE WAS MOVED TO THE DIAGNOSTIC ZONE. THE PHYSICIAN MANAGED TO PULL IT OUT SAFELY FROM THE PATIENT. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372274 ↗
• InjuryDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 5FR IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR A UTERINE ARTERY EMBOLIZATION PROCEDURE. A FEMORAL APPROACH WAS USED TO ACCESS THE MILDLY CALCIFIED ECCENTRICALLY SHAPED LESION. THE ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, APPROXIMATELY 3-5CM OF THE TIP OF THE CATHETER DETACHED INSIDE THE PATIENT AND WAS VISIBLE ON FLUOROSCOPY. THE TIP WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11003788 ↗
• InjuryMar 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURED. DURING A PROCEDURE INVOLVING AN IMAGER II ANGIOGRAPHIC CATHETER, IT WAS NOTED THAT THE TIP WAS DETACHED. THE PHYSICIAN SNARED THE TIP OUT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH THE OTHER DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844576 ↗
• InjuryDec 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINS IN THE PATIENT. A IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE AND REMAINS IN THE LESION. THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED INTERVENTION OCCURRED TO REMOVE THE DEVICE COMPONENT AND THE PATIENT WAS STABLE AFTER INTERVENTION.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9503426 ↗