IMAGER™ II M001315150Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729737094), received between Nov 25, 2019 and Aug 31, 2020 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 PIGTAIL 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 10474555 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F PIGTAIL 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 10474549 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F PIGTAIL 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 10474544 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F PIGTAIL 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 10474520 ↗
• MalfunctionFeb 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JAN2020. AN IMAGER II/5/PIGTAIL/100/038 BX5 ANGIOGRAPHIC CATHETER RETURNED WITH NO KNOWN COMPLAINT. DEVICE ANALYSIS FOUND THE TIP WAS SEPARATED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED IN A PROCEDURE. THE DEVICE WAS TESTED AT THE HOSPITAL WAREHOUSE AND WAS FOUND TO BE FRACTURED.

  Patient problems: No Patient Involvement

  MAUDE report 9706536 ↗
• MalfunctionJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP BROKE. THE IMAGER II ANGIOGRAPHIC CATHETER WAS REMOVED FROM THE PACKAGING FOR REVIEW. UPON TOUCHING THE TIP, THE TIP BROKE. THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 9559004 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP BROKE. THE IMAGER II ANGIOGRAPHIC CATHETER WAS REMOVED FROM THE PACKAGING FOR REVIEW. UPON TOUCHING THE TIP, THE TIP BROKE. THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 9520275 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP BROKE. THE IMAGER II ANGIOGRAPHIC CATHETER WAS REMOVED FROM THE PACKAGING FOR REVIEW. UPON TOUCHING THE TIP, THE TIP BROKE. THE DEVICE WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520265 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP BROKE. THE IMAGER II ANGIOGRAPHIC CATHETER WAS REMOVED FROM THE PACKAGING FOR REVIEW. UPON TOUCHING THE TIP, THE TIP BROKE. THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 9520263 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP BROKE. THE IMAGER II ANGIOGRAPHIC CATHETER WAS REMOVED FROM THE PACKAGING FOR REVIEW. UPON TOUCHING THE TIP, THE TIP BROKE. THE DEVICE WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520261 ↗
• InjuryDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE LUNG ARTERY, AN IMAGER DIAGNOSTIC CATHETER WAS SELECTED TO USE. HOWEVER, DURING LOWER EXTREMITY VEIN AGIOGRAPHY THE TIP OF THE DEVICE DETACHED IN THE LESION. THE PHYSICIAN ATTEMPTED TO SNARE THE TIP BUT RETRIEVAL WAS UNSUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TIP DETACHED DURING ADVANCEMENT AND THE DEVICE WAS COMPLETELY REMOVED BY LOWER EXTREMITY ANGIOGRAPHY.

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

  MAUDE report 9474085 ↗
• InjuryNov 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE TIP DETACHMENT OCCURRED. AN IMAGER II DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS OBSERVED THAT THE CATHETER TIP DETACHED. THE DETACHED TIP WAS SNARED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371670 ↗