IMAGER™ II M001314050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729736073), received between Nov 1, 2019 and Aug 19, 2025 — classified as 1 death, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER TIP DISLODGED, AND A PORTION REMAINED IN THE ARTERY. AN IMAGER II/5/BERN/100/038 BX5 ANGIOGRAPHIC CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL AND PROXIMAL POPLITEAL ARTERIES. AFTER DEPLOYMENT OF THE CATHETER, IT WAS NOTED THAT THE PROXIMAL TIP DISLODGED AND REMAINED IN THE ARTERY. AFTER REMOVAL OF THE CATHETER, IT WAS INSPECTED, AND IT WAS NOTED THAT THE PROXIMAL TIP HAD BROKEN INTO THREE SEPARATE PIECES. THE DISLODGED PIECE IN THE PATIENT COULD NOT BE REMOVED AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE HUMIDITY OF THE CATH LAB WAS 60-65%. HYDROGEN PEROXIDE WAS USED TO CLEAN THE LAB MONTHLY FOR FUMIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22841615 ↗
• InjuryJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND WAS LEFT INSIDE THE PATIENT. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIZZINESS AND CEREBRAL VASCULAR STENOSIS. ON (B)(6) 2024, AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN TOTAL CEREBRAL ANGIOGRAPHY, WHICH WAS PERFORMED UNDER LOCAL ANESTHESIA. A 0.035, 150CM ZIPWIRE GUIDEWIRE WAS USED TO DELIVER THE CATHETER TO THE AORTIC ARCH. THE PHYSICIAN STARTED ROTATING THE IMAGER II CATHETER TO GET IT INTO THE LEFT COMMON CAROTID ARTERY. AFTER A FEW ATTEMPTS, IT WAS NOTED THAT THE CATHETER'S TIP WAS ABNORMAL, AND THE TIP DETACHED AND BEGAN MOVING TOWARD THE DESCENDING AORTA. THE CATHETER WAS IMMEDIATELY REMOVED, AND OUTSIDE THE PATIENT IT WAS OBSERVED THAT THE TIP HAD FRACTURED. UPON IMMEDIATE EXAMINATION, IT WAS DETERMINED THAT THE TIP WAS LOCATED IN THE LEFT RENAL ARTERY BRANCH. THE PATIENT WAS ASYMPTOMATIC. THE FRAGMENT WAS APPROXIMATELY 1CM AND REMAINED IN THE PATIENT'S LEFT KIDNEY. NO ATTEMPTS TO REMOVE THE FRAGMENT WERE MADE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19619618 ↗
• MalfunctionSep 3, 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 10488121 ↗
• MalfunctionSep 3, 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 10488120 ↗
• MalfunctionSep 3, 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 10488048 ↗
• 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 10474616 ↗
• 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 10474554 ↗
• MalfunctionAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2020. A 5F BERN IMAGER II ANGIOGRAPHIC CATHETER WAS RETURNED TO BSC FROM A CUSTOMER WITH NO REPORTED COMPLAINT AGAINST THE DEVICE. DEVICE ANALYSIS ON THE RETURNED DEVICE FOUND THAT THE DEVICE FAILED TENSILE TESTING LEADING TO A TIP DETACHMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10417812 ↗
• DeathNov 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER TIP WAS FRACTURED AND DETACHMENT ENCOUNTERED. A II/5/BERN/100/038 BX5 IMAGER II ANGIOGRAPIC CATHETER WAS SELECTED FOR USE IN THE INTERNAL CAROTID ARTERY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS FRACTURED AND DETACHED. THE PHYSICIAN TRIED TO WITHDRAW THE FRACTURED CATHETER AT ONCE BUT FAILED. THE LENGTH OF THE CATHETER THAT REMAINED IN THE PATIENT'S BODY WAS 2.8CM. THE PHYSICIAN TRIED TO REMOVE THE FRACTURED PART WITH A SNARE BUT FAILED. THERE WERE NO PATIENT COMPLICATIONS AS THIS TIME AND THE PATIENT WAS STABLE. APPROXIMATELY 5 HOURS AFTER DEVICE USE, THE PATIENT EXPERIENCED DECREASED RESPIRATORY HEART RATE, LOW BLOOD PRESSURE, AND WAS ON ASSISTED BREATHING WITH UPPER TRACHEAL INTUBATION. AFTER RESCUE, THE PATIENT WAS TEMPORARILY STABLE AND WAS TRANSFERRED TO ICU 30 MINUTES LATER. THE PATIENT WAS TRANSFERRED TO OTHER HOSPITAL. IT WAS FURTHER REPORTED THAT THE PATIENT SANK INTO THE COMA WHEN THE PHYSICIAN TRIED TO SNARE THE DEVICE FRAGMENT.

  Patient problems: Bradycardia; Coma; Death; Device Embedded In Tissue or Plaque; Low Blood Pressure/ Hypotension; Respiratory Distress

  MAUDE report 9265933 ↗