IMAGER™ II M001314060Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729736080), received between Mar 16, 2020 and Aug 16, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.

Recalls naming this device

1. Aug 24, 2026Open, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN IMAGER II WAS SELECTED FOR USE IN A DIGITAL SUBTRACTION ANGIOGRAPHY PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS KINKED, AND TIP WAS BROKEN WHEN IT WAS ADVANCED TO THE CAROTID ARTERY. THE DEVICE, INCLUDING THE BROKEN PARTS WERE ABLE TO BE REMOVED INTO THE SHEATH AND FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560818 ↗
• MalfunctionMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN IMAGER II WAS SELECTED FOR USE IN A VENOGRAPHY VENOPLASTY PROCEDURE. DURING THE PROCEDURE, THE GREY PART OF THE DEVICE WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485359 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F BERN IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2019-13161. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT A TENSILE STRENGTH TEST ON THE RETURNED DEVICE RESULTING IN A TIP DETACHMENT CONCLUDING THAT THE DEVICE FAILED TO MEET SPECIFICATION. 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 10474607 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F BERN IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2019-13161. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT A TENSILE STRENGTH TEST ON THE RETURNED DEVICE RESULTING IN A TIP DETACHMENT CONCLUDING THAT THE DEVICE FAILED TO MEET SPECIFICATION. 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 10474604 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F BERN IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2019-13161. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT A TENSILE STRENGTH TEST ON THE RETURNED DEVICE RESULTING IN A TIP DETACHMENT CONCLUDING THAT THE DEVICE FAILED TO MEET SPECIFICATION. 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 10474603 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F BERN IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2019-13161. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT A TENSILE STRENGTH TEST ON THE RETURNED DEVICE RESULTING IN A TIP DETACHMENT CONCLUDING THAT THE DEVICE FAILED TO MEET SPECIFICATION. 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 10474552 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F BERN IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2019-13161. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT A TENSILE STRENGTH TEST ON THE RETURNED DEVICE RESULTING IN A TIP DETACHMENT CONCLUDING THAT THE DEVICE FAILED TO MEET SPECIFICATION. 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 10474521 ↗
• MalfunctionMar 16, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT SEAL COMPROMISED OCCURRED. AN IMAGER CATHETER WAS INSPECTED UPON RECEIPT OF THE DEVICE. DURING INSPECTION, IT WAS DETECTED THAT IMAGER ANGIOGRAPHIC CATHETER WAS DAMAGED. THE PACKAGING WAS OPEN ON THE SIDE OF THE BOSTON BOX. NO PATIENT WAS INVOLVED AS IT DID NOT OCCUR DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9836323 ↗