IMAGER™ II M001314670Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729736691), received between Jul 22, 2020 and Oct 13, 2022 — classified as 1 injury, 6 malfunctions.

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

• InjuryOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ARTERIOVENOUS FISTULA IN THE RIGHT ARM. THE IMAGER II/5/C2/65/035 CATHETER WAS SELECTED FOR USE. DURING AN ATTEMPT TO CANNULATE THE VESSEL, THE TIP OF THE CATHETER BROKE. THERE WAS NO RESISTANCE FELT AND NO INTERACTION WITH ANOTHER DEVICE. THE DETACHED TIP WAS REMOVED THROUGH SURGERY. THE PROCEDURE WAS CANCELLED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600696 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HOSPITAL PREVIOUSLY EXPERIENCED TIP DETACHMENTS WITH THREE 5FR IMAGER II ANGIOGRAPHIC CATHETERS CAPTURED WITHIN MANUFACTURER REPORT #S 2134265-2018-03728, 2134265-2018-04054, AND 2134265-2018-04096. THE PHYSICIAN AND HIS TEAM TOOK THIS 5FR IMAGER II ANGIOGRAPHIC CATHETER OF THE SAME BATCH AND PURPOSELY BROKE THE TIP OF THE CATHETER TO PROVE THE FRAGILITY OF THE DEVICE. THE CATHETER WAS NOT USED ON A PATIENT. THIS EVENT IS ASSOCIATED WITH PREVIOUSLY REPORTED FIELD ACTION (B)(4) WITH PRODUCT BEING REMOVED FROM THE FIELD.

  Patient problems: No Patient Involvement

  MAUDE report 10577659 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HOSPITAL PREVIOUSLY EXPERIENCED TIP DETACHMENTS WITH THREE 5FR IMAGER II ANGIOGRAPHIC CATHETERS CAPTURED WITHIN MANUFACTURER REPORT #S (B)(4). THE PHYSICIAN AND HIS TEAM TOOK THIS 5FR IMAGER II ANGIOGRAPHIC CATHETER OF THE SAME BATCH, AND PURPOSELY BROKE THE TIP OF THE CATHETER TO PROVE THE FRAGILITY OF THE DEVICE. THE CATHETER WAS NOT USED ON A PATIENT. THIS EVENT IS ASSOCIATED WITH PREVIOUSLY REPORTED FIELD ACTION 92484513-FA WITH PRODUCT BEING REMOVED FROM THE FIELD.

  Patient problems: No Patient Involvement

  MAUDE report 10577655 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HOSPITAL PREVIOUSLY EXPERIENCED TIP DETACHMENTS WITH THREE 5FR IMAGER II ANGIOGRAPHIC CATHETERS CAPTURED WITHIN MANUFACTURER REPORT #S 2134265-2018-03728, 2134265-2018-04054, AND 2134265-2018-04096. THE PHYSICIAN AND HIS TEAM TOOK THIS 5FR IMAGER II ANGIOGRAPHIC CATHETER OF THE SAME BATCH AND PURPOSELY BROKE THE TIP OF THE CATHETER TO PROVE THE FRAGILITY OF THE DEVICE. THE CATHETER WAS NOT USED ON A PATIENT. THIS EVENT IS ASSOCIATED WITH PREVIOUSLY REPORTED FIELD ACTION 92484513-FA WITH PRODUCT BEING REMOVED FROM THE FIELD.

  Patient problems: No Patient Involvement

  MAUDE report 10577654 ↗
• MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE OFF. A 5F C2 IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR A URETERIC STENT INSERTION PROCEDURE. AN ANTEGRADE APPROACH WAS USED VIA THE LEFT NEPHROSTOMY TUBE. THE IMAGER II CATHETER WAS PLACED INTO THE ENTRY SHEATH AFTER BEING FLUSHED WITH HEPARINIZED SALINE AND LUBRICATED WITH NORMAL SALINE. WHEN THE CATHETER WAS IN THE LEFT URETER, IT WAS DISCOVERED THAT THE DISTAL TIP WAS BROKEN OFF BUT STILL ATTACHED TO THE CATHETER. THE CATHETER WAS REMOVED AND DISCARDED. ANOTHER OF THE SAME PRODUCT AND BATCH NUMBER WAS OPENED. DURING INSPECTION OF THE CATHETER, WHICH INVOLVED FLUSHING AND LUBRICATING, THE DISTAL TIP OF THE CATHETER DETACHED IN THE RADIOLOGIST'S HAND. A THIRD CATHETER WAS THEN OPENED TO CHECK THE TIP. THE TIP WAS VERY FRAGILE AND EASILY REMOVED FROM THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. THE PATIENT WAS ADMITTED FOR ROUTINE OBSERVATIONS POST-PROCEDURE AS PRE-PLANNED, AND NO ESCALATION OF CARE WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308661 ↗
• MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE OFF. A 5F C2 IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR A URETERIC STENT INSERTION PROCEDURE. AN ANTEGRADE APPROACH WAS USED VIA THE LEFT NEPHROSTOMY TUBE. THE IMAGER II CATHETER WAS PLACED INTO THE ENTRY SHEATH AFTER BEING FLUSHED WITH HEPARINIZED SALINE AND LUBRICATED WITH NORMAL SALINE. WHEN THE CATHETER WAS IN THE LEFT URETER, IT WAS DISCOVERED THAT THE DISTAL TIP WAS BROKEN OFF BUT STILL ATTACHED TO THE CATHETER. THE CATHETER WAS REMOVED AND DISCARDED. ANOTHER OF THE SAME PRODUCT AND BATCH NUMBER WAS OPENED. DURING INSPECTION OF THE CATHETER, WHICH INVOLVED FLUSHING AND LUBRICATING, THE DISTAL TIP OF THE CATHETER DETACHED IN THE RADIOLOGIST'S HAND. A THIRD CATHETER WAS THEN OPENED TO CHECK THE TIP. THE TIP WAS VERY FRAGILE AND EASILY REMOVED FROM THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. THE PATIENT WAS ADMITTED FOR ROUTINE OBSERVATIONS POST-PROCEDURE AS PRE-PLANNED, AND NO ESCALATION OF CARE WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308647 ↗
• MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE OFF. A 5F C2 IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR A URETERIC STENT INSERTION PROCEDURE. AN ANTEGRADE APPROACH WAS USED VIA THE LEFT NEPHROSTOMY TUBE. THE IMAGER II CATHETER WAS PLACED INTO THE ENTRY SHEATH AFTER BEING FLUSHED WITH HEPARINIZED SALINE AND LUBRICATED WITH NORMAL SALINE. WHEN THE CATHETER WAS IN THE LEFT URETER, IT WAS DISCOVERED THAT THE DISTAL TIP WAS BROKEN OFF BUT STILL ATTACHED TO THE CATHETER. THE CATHETER WAS REMOVED AND DISCARDED. ANOTHER OF THE SAME PRODUCT AND BATCH NUMBER WAS OPENED. DURING INSPECTION OF THE CATHETER, WHICH INVOLVED FLUSHING AND LUBRICATING, THE DISTAL TIP OF THE CATHETER DETACHED IN THE RADIOLOGIST'S HAND. A THIRD CATHETER WAS THEN OPENED TO CHECK THE TIP. THE TIP WAS VERY FRAGILE AND EASILY REMOVED FROM THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. THE PATIENT WAS ADMITTED FOR ROUTINE OBSERVATIONS POST-PROCEDURE AS PRE-PLANNED, AND NO ESCALATION OF CARE WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308641 ↗