IMAGER™ II M001314830Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729736851), received between Jun 24, 2020 and Aug 31, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F SHK IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2020-08495. 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 10474585 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F SHK IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2020-08495. 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 10474581 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F SHK IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2020-08495. 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 10474580 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F SHK IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2020-08495. 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 10474559 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F SHK IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER ASSOCIATED WITH MDR ID 2134265-2020-08495. 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 10474556 ↗
• InjuryJun 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN IMAGER II CATHETER WAS SELECTED FOR USE IN A RENAL EMBOLIZATION PROCEDURE. THE IMAGER II WAS PLACED INTO THE BODY OVER A .035 NON-BSC GUIDEWIRE. WHILE SCREENING THE CATHETER THROUGH THE HEART IT WAS NOTED THAT THE DISTAL PART OF THE CATHETER BECAME DETACHED. THIS ENDED UP FLOATING OFF THE WIRE AND WAS INITIALLY LODGED IN THE AORTA. A SNARE WAS THEN USED IN AN ATTEMPT TO RETRIEVE THE CATHETER TIP, BUT ON TWO OCCASIONS THE SNARE SLICED THROUGH THE CATHETER AND THEREFORE THERE WERE THEN THREE PIECES OF CATHETER TIP FLOATING THROUGH THE ARTERIES. THE SNARE WAS USED TO SUCCESSFULLY RETRIEVE ONE OF THESE PIECES AND WAS REMOVED FROM THE RIGHT CIRCUMFLEX FEMORAL ARTERY. A LONG DIFFERENT SNARE WAS THEN USED TO ATTEMPT TO SNARE THE REMAINING PIECES WHICH HAD NOW TRAVELLED MORE DISTAL, BUT WITHOUT SUCCESS. THE MAIN BODY OF THE CATHETER TIP HAS BECOME LODGED WITHIN THE RIGHT POSTERIOR TIBIAL ARTERY AND A SMALLER PIECE HAS ALSO BECOME LODGED IN THE RIGHT DORSALIS PEDIS ARTERY. THE RIGHT FOOT WAS VIABLE. AFTER APPROXIMATELY THREE HOURS OF ATTEMPTING TO REMOVE THE FRAGMENTS, IT WAS DECIDED TO LEAVE THE FRAGMENTS WITHIN THE PATIENT RATHER THAN OPERA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10191775 ↗