ANGIOGUARDRecalls & reported problems across all models
Cordis Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one ANGIOGUARD model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 6
We found 7 models of ANGIOGUARD by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between May 26, 2017 and Jul 13, 2026 — classified as 1 injury, 43 malfunctions.
The most frequently reported specific device problem is “Stretched” (14 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ANGIOGUARD recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 24, 2023Open, Classified
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Z-1489-2023 · Root cause: Vendor change control · Recall details · FDA record ↗
- Mar 24, 2023Open, Classified
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Z-1487-2023 · Root cause: Vendor change control · Recall details · FDA record ↗
- Mar 24, 2023Open, Classified
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Z-1486-2023 · Root cause: Vendor change control · Recall details · FDA record ↗
- Mar 24, 2023Open, Classified
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Z-1485-2023 · Root cause: Vendor change control · Recall details · FDA record ↗
- Mar 24, 2023Open, Classified
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Z-1484-2023 · Root cause: Vendor change control · Recall details · FDA record ↗
- Mar 24, 2023Open, Classified
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Z-1483-2023 · Root cause: Vendor change control · Recall details · FDA record ↗
Most reported ANGIOGUARD problems
Device problems
- Stretched14
- Unraveled Material13
- Difficult or Delayed Positioning10
- Detachment of Device or Device Component9
- Retraction Problem6
- Material Twisted/Bent5
- Defective Component3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient3
ANGIOGUARD models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ANGIOGUARD 501814RMCTemporary Carotid Catheter For Embolic Capture1 recall14 reports
- ANGIOGUARD 601814RMCTemporary Carotid Catheter For Embolic Capture1 recall11 reports
- ANGIOGUARD 701814RMCTemporary Carotid Catheter For Embolic Capture1 recall6 reports
- ANGIOGUARD 401814RMCTemporary Carotid Catheter For Embolic Capture1 recall4 reports
- ANGIOGUARD 501814RECTemporary Carotid Catheter for Embolic Capture1 recall2 reports
- ANGIOGUARD 801814RMCTemporary Carotid Catheter For Embolic Capture1 recall2 reports
- ANGIOGUARD 601814RECTemporary Carotid Catheter for Embolic Capture5 reports
Recent ANGIOGUARD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798641 ↗MalfunctionJul 8, 2026Stretched; Unraveled Material; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751918 ↗MalfunctionMay 13, 2026Material Twisted/Bent
AS REPORTED, THE FILTER ON A 6MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM MIGRATED DURING STENT INSERTION. THE FILTER WAS ABLE TO BE CAPTURED AND REMOVED FROM THE PATIENT, AND ANOTHER UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE. THE TARGET VESSEL WAS THE CAROTID ARTERY, WITH MILD CALCIFICATION, MILD TORTUOSITY, 80% STENOSIS, AND NO CHRONIC TOTAL OCCLUSION. IT WAS REPORTED THAT THE FILTER WAS SIZED LARGER THAN THE VESSEL AS INSTRUCTED IN THE IFU; HOWEVER, THE TARGET VESSEL DIAMETER WAS 8 MM. THE DEVICE WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF ANGIOGUARD. THERE WAS NO RESISTANCE OR FRICTION BETWEEN THE STENT DELIVERY SYSTEM AND THE ANGIOGUARD GUIDEWIRE THAT CAUSED FILTER MIGRATION DURING INSERTION, AND THERE WAS NO INDICATION THAT EITHER THE ANGIOGUARD GUIDEWIRE OR THE FILTER WAS SEPARATED. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED THE FI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164309 ↗MalfunctionMar 24, 2026Stretched; Increase in Suction
AS REPORTED, WITH ALL MIGRATION CLIPS REMOVED ON THE 8MM ANGIOGUARD, THE DEVICE WAS HAVING ISSUES BEING REMOVED FROM THE HOOP. A DIFFERENT DEVICE HAD TO BE OPENED AND USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS OPENED AND PREPPED PER INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPER PER THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN HAD EXTREME DIFFICULTY REMOVING THE DEVICE. A NEW ANGIOGUARD DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDENDUM: THE PE RESULTS PRESENTED THE DISTAL TIP (ECGW)-UNRAVELED/STRETCHED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674972 ↗MalfunctionMar 16, 2026Defective Component; Detachment of Device or Device Component
AS REPORTED, THE 5MM ANGIOGUARD WAS INSERTED AND SUCCESSFULLY DEPLOYED. UPON REMOVING THE DEVICE AT THE END OF THE PROCEDURE, PHYSICIAN NOTICED THAT THE BASKET HAD BECOME DAMAGED. HE BELIEVED THIS WAS DUE TO THE HEAVY CIRCUMFERENTIAL CALCIUM IN THE ICA. HE TOOK A PICTURE OF THE ICA TO ENSURE THAT NOTHING EMBOLIZED, WHICH IT HAD NOT, AND THE CASE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS OPENED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE FILTER BASKET WAS RECEIVED SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607455 ↗MalfunctionFeb 12, 2026Stretched; Unraveled Material; Material Twisted/Bent
AS REPORTED, THE DOCTOR TRIED TO USE A 5MM ANGIOGUARD FOR THE CAROTID ARTERY STENTING (CAS) PROCEDURE. HOWEVER, THE WIRE WAS KINKED AND COULD NOT BE USED BECAUSE IT COULD NOT CROSS THE BLOOD VESSEL. THE ANGIOGUARD ASSOCIATED WITH THE REPORTED WIRE KINKING WAS NOT USED TO COMPLETE THE PROCEDURE. THE CASE WAS COMPLETED USING A NEW ANGIOGUARD DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ABNORMALITIES WERE NOTED PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS NOT SEATED IN THE FILTER BASKET INTRODUCER BUT WAS MANUALLY INSERTED. THE MANUAL RE-SEATING DESCRIBED ABOVE WAS NOT RELATED TO THE DOCKING STEP. NO DIFFICULTY WAS ENCOUNTERED FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE ANTI-MIGRATION CLIP CLOSEST TO THE FILTER INTRODUCER REMAINED IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED. DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH WAS NOT DIFFICULT. NO DIFFICULTY OR ABNORMAL MANIPULATION WAS REPORTED. NO DIFFICULTY WAS ENCOUNTERED WHILE DOCKING THE FILTER B
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24329588 ↗MalfunctionJan 13, 2026Detachment of Device or Device Component
AS REPORTED, PHYSICIAN AND THE TECHNICIAN WERE PREPPING A 6MM ANGIOGUARD EXTRA SUPPORT DEVICE. WHEN THEY ATTEMPTED TO BRING THE BASKET FROM THE EMBOLI CAPTURE INTO THE DEPLOYMENT SHEATH, THEY HAD A TOUGH TIME AND STRUGGLED TO GET THE BASKET INTO THE DEPLOYMENT SHEATH. THEY WERE ULTIMATELY SUCCESSFUL AND SUCCESSFULLY USED AND RETRIEVED THE DEVICE FOR THE CASE. THE PRODUCT EVALUATION OBSERVED THE FILTER BASKET AND DISTAL TIP WERE SEPARATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION RELATED TO THE OBSERVED DAMAGES WAS REQUESTED, BUT NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24056471 ↗MalfunctionDec 29, 2025Defective Component; Defective Component
AS REPORTED, THE BASKET OF A 6MM EXTRA SUPPORT ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM COULD NOT BE ADVANCED INTO THE DELIVERY SHEATH DURING PREPARATION. THE DEVICE WAS REMOVED FROM THE COIL-TUBING DISPENSER, AND THE PHYSICIAN SUBMERGED THE BASKET AND DEPLOYMENT SHEATH IN FLUSH, AFTER WHICH THE TECHNICIAN WAS ABLE TO GENTLY PULL THE BASKET INTO THE SHEATH. THE ANGIOGUARD WAS THEN SUCCESSFULLY DEPLOYED, AND THE CAROTID PROCEDURE WAS COMPLETED. AFTER REMOVAL WITH THE RETRIEVAL CATHETER, THE PHYSICIAN OBSERVED THAT ONE SIDE OF THE BASKET APPEARED DAMAGED AND MAY HAVE CAUGHT ON SOMETHING DURING WITHDRAWAL. THERE WAS NO REPORTED PATIENT INJURY. THE CASE WAS FINISHED SUCCESSFULLY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907569 ↗MalfunctionDec 18, 2025Stretched; Unraveled Material; Stretched; Unraveled Material
AS REPORTED, A 7MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM COULD NOT BE PREPPED PROPERLY. DURING PREPARATION, THE FILTER WAS UNABLE TO BE PULLED INTO THE DEPLOYMENT SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT AND ANOTHER 7MM ANGIOGUARD ECGW SYSTEM WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE TO THE DEVICE WAS OBSERVED PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER. DURING FLUSHING, SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB, AND THERE WAS NO DIFFICULTY FLUSHING THE DEVICE. THE TWO PROXIMAL ANTIMIGRATION CLIPS ON THE DEVICE WERE REMOVED PRIOR TO ATTEMPTING TO LOAD OR DOCK THE DEVICE, AND THE ANTIMIGRATION CLIP CLOSEST TO THE FILTER WAS LEFT IN PLACE DURING THIS PROCESS. THE DEVICE WAS NOT ALTERED AFTER DECIDING TO DISCONTINUE ITS USE, AND NO ATTEMPTS BEYOND THE ORIGINAL IFU PREPARATION WERE MADE TO PULL ON THE DISTAL TIP TO RESET THE FILTER BASKET. THE DEVICE WILL BE RETURNED FOR EVALUATION.ADDENDUM: PRODUCT EVALUATION REVEALED THAT THE DISTAL TIP WAS UNRAVELE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843708 ↗MalfunctionDec 17, 2025Stretched; Unraveled Material; Material Twisted/Bent; Stretched; Unraveled Material; Material Twisted/Bent
AS REPORTED, THE DISTAL TIP A 5MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) WAS KINKED AND WAS UNABLE TO CROSS THE VESSEL. THE DEVICE WAS NOT USED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED THAT THE FILTER BASKET WAS KINKED AND THE DISTAL TIP IS UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831767 ↗MalfunctionDec 5, 2025Retraction Problem; Stretched; Unraveled Material; Retraction Problem; Stretched; Unraveled Material
AS REPORTED, A 6MM ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (EPD) USED IN A CAROTID ARTERY STENTING PROCEDURE COULD NOT BE RECAPTURED. THERE WAS NO REPORTED PATIENT INJURY. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY ADVANCING THE CAPTURE SHEATH TO THE LESION. DURING RETRIEVAL, THE RETRIEVAL SHEATH WAS ADVANCED WHILE THE FILTER WIRE WAS FIXED. THE FILTER WAS DISTAL ENOUGH FROM THE LESION TO PREVENT INTERACTION WITH THE BALLOONS OR SDS USED. THERE WAS NO DEBRIS IN THE FILTER BASKET AFTER REMOVAL. THE DEVICE HAD BEEN PREPARED AND USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF THE ANGIOGUARD RX EMBOLIC PROTECTION DEVICE AND HAD USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727745 ↗MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent
AS REPORTED, AN ISSUE OCCURRED DURING LOADING OF A 5MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM PRIOR TO THE PROCEDURE AND THE DEVICE FAILED. A NON-CORDIS EMBOLIC PROTECTION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS NOT FULLY SEATED IN THE FILTER BASKET INTRODUCER. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED THAT THE FILTER BASKET IS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639316 ↗MalfunctionOct 21, 2025Stretched; Unraveled Material; Stretched; Unraveled Material
AS REPORTED, THE 5MM ANGIOGUARD TIP BENT DURING THE PROCEDURE. RE-ENTRY IS NOT POSSIBLE DUE TO BENDING. THE CASE WAS COMPLETED USING AN ANGIOGUARD DEVICE THAT HAD BEEN PREPARED AS A PRECAUTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER. NO DIFFICULTY WAS ENCOUNTERED WHILE FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH, AND SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE ANTI-MIGRATION CLIP CLOSEST TO THE FILTER INTRODUCER WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH. THERE WAS NO DIFFICULTY DURING DOCKING, AND THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. THE LESION WAS CALCIFIED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348332 ↗MalfunctionSep 19, 2025Stretched; Unraveled Material; Stretched; Unraveled Material
AS REPORTED, THE PHYSICIAN WHILE PREPPING THE DEVICE COULD NOT LOAD THE FILTER OF A 5MM ANGIOGUARD RX EMBOLIC PROTECTION DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER ANGIOGUARD WAS USED AND THE FILTER SUCCESSFULLY LOADED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN STERILE FIELD. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS NOT FULLY SEATED IN THE FILTER BASKET INTRODUCER AND WAS MANUALLY INSERTED. NO DIFFICULTY WAS ENCOUNTERED WHILE FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. THE TORQUE DEVICE WAS LOCKED ONTO THE GUIDEWIRE, AND THE CAPTURE SHEATH COIL DISPENSER WAS FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE ANTI-MIGRATION CLIP LOCATED CLOSEST TO THE FILTER INTRODUCER WAS NOT APPLICABLE IN THIS CASE. WHILE DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH, SOME DIFFICULTY WAS ENCOUNTERED. IT IS NOTED THAT WHEN PROPERLY DOCKED, APPROXIMATELY HALF OF THE FILTER BASKET REMAINS VISIBLE OUT OF THE END OF THE DEPLOYMENT SHEATH. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23102225 ↗MalfunctionSep 5, 2025Material Twisted/Bent; Material Twisted/Bent
AS REPORTED, A 5MM ANGIOGUARD FILTER BASKET DID NOT FULLY WITHDRAW INTO THE DEPLOYMENT SHEATH HUB, WHICH MAY HAVE SHEARED THE POROUS MEMBRANE WHEN WITHDRAWN THROUGH THE HOOP. UPON REMOVAL FROM THE HOOP, THE DEVICE TIP WAS INSPECTED AND APPEARED TO HAVE PIECES OF THE FILTER EXPOSED IN A WAY THAT INDICATED THE DEVICE WAS UNFIT FOR SAFE UTILITY. THE DEVICE WAS DISCARDED WITHOUT USE, AND A SECOND ANGIOGUARD WAS PREPPED DEPLOYED AS INTENDED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPPED BY THE PHYSICIAN. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22979834 ↗
Other Cordis Corporation products
All Cordis Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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