IMPEDE Embolization Plug IMP-10 (UDI 00810041650023)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810041650023), received between Jul 20, 2020 and Sep 13, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Malposition of Device; Malposition of Device

  THIS WAS A DISSECTION PATIENT THAT WAS GOING TO BE TREATED IN STAGES SURGICALLY. THIS FIRST STAGE INVOLVED CAROTID/SUBCLAVIAN (LSA) BYPASS AND EMBOLIZATION WITH AN IMP-10. THE LSA WAS FUNNEL-SHAPED AND ESTIMATED TO BE 9 - 13MM, AND 10 - 11MM AT THE TARGET LOCATION FOR EMBOLIZATION. A 5FR COOK FLEXOR SHEATH WAS USED WITH THE IMP-10, A 6FR SHEATH WAS USED WITH THE ABBOTT AMPLATZER. AFTER THE CAROTID/SUBCLAVIAN BYPASS, A SHEATH WAS INTRODUCED FROM THE BRACHIAL INTO THE LSA AND AN IMP-10 WAS DEPLOYED AS A STAND ALONE DEVICE (NO TEVAR) INTO THE LSA TARGET LOCATION. THE IMP-10 WAS UNDERSIZED RELATIVE TO THE VESSEL AND MIGRATED FROM THE LSA TO THE ILIAC BIFURCATION UPON DEPLOYMENT. THE PHYSICIAN COMMENTED THAT THE FLOW DYNAMICS LIKELY CHANGED IN THE LSA AFTER THE BYPASS, CAUSING FLOW TO BE DIRECTED FROM THE LSA DOWN TOWARD THE AORTA (AS OPPOSED TO NORMAL FLOW UP HIGHER IN THE LSA). THIS COULD HAVE LED TO THE PLUG MIGRATING TO THE ILIAC BIFURCATION. AN ENSNARE WAS USED FROM THE BRACHIAL ACCESS TO RETRIEVE THE PLUG. AFTER MULTIPLE ATTEMPTS, THE ANCHOR COIL OF THE IMP-10 WAS SUCCESSFULLY SNARED AND THE ENTIRE IMPLANT WAS BROUGHT BACK UP TO THE LSA. NOTE THAT WHEN THE PLUG WAS REMOVED THROUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739264 ↗
• MalfunctionAug 2, 2023Malposition of Device; Malposition of Device

  EVAR WAS PLANNED IN COMBINATION WITH INTERNAL ILIAC ARTERY (IIA) EMBOLIZATION TO TREAT AN ENDOLEAK. THE AIM WAS TO FIRST EMBOLIZE THE IIA (~ 9-9.5 MM IN DIAMETER) WITH AN IMP-10 DEVICE. ACCESS WAS GAINED IPSALATERALLY, FROM THE EXTERNAL ILIAC TO THE INTERNAL ILIAC. BECAUSE OF THIS APPROACH, THERE WAS A HIGH DEGREE OF ANGULATION (MORE THAN 90 DEGREES). A MEDTRONIC LAUNCHER JR 6F WAS USED FOR DELIVERY. A 6F LAUNCHER WAS PLACED IN THE IIA AND HAD AN S-CURVE CONFIGURATION. THERE WAS DIFFICULTY IN NAVIGATING THE PLUG THROUGH THE S-CURVE. THE PLUG WAS FORWARDED TO THE END OF THE CURVE USING A STIFF WIRE. AT THIS POINT, BECAUSE OF TOO LITTLE SUPPORT IN THE IIA, THE CATHETER LOST POSITION AND THE PLUG WAS UNINTENTIONALLY DEPLOYED IN THE COMMON ILIAC. ALL OF THIS OCCURRED WITHIN THE WORKING TIME. EVAR WAS PERFORMED AND THE PHYSICIAN DECIDED TO "OVER-STENT" THE IMP-10 IN THE COMMON ILIAC TO PREVENT FURTHER MIGRATION AND SECURE THE IMP-10 BETWEEN THE STENT AND THE VESSEL WALL. DURING EVAR, THE PLUG MIGRATED DISTALLY AND EMBOLIZED THE COMMON FEMORAL. AFTER EVAR, THE PLUG WAS REMOVED FROM THE FEMORAL SURGICALLY, IN ONE PIECE, BY OPENING THE GROIN, CLAMPING THE ARTERY, AND EXTRACTING. THE PLUG W

  Patient problems: Foreign Body Embolism

  MAUDE report 17447132 ↗
• MalfunctionMar 1, 2023Use of Device Problem; Use of Device Problem

  THE PHYSICIAN WAS DELIVERING AN IMP-10 DEVICE USING A 7FR APT MEDICAL GUIDE CATHETER TO EMBOLIZE A RIGHT OVARIAN VEIN. DURING DEVICE DEPLOYMENT, THE IMP-10 ANCHOR COIL FORMED IN A STRAIGHT CONFIGURATION, INSTEAD OF A HELICAL SHAPE. BECAUSE OF THIS, THE PHYSICIAN CHOSE TO REMOVE THE CATHETER CONTAINING THE DEVICE. AFTER REMOVING THE CATHETER FROM THE PATIENT, THE PHYSICIAN RAN A GUIDEWIRE THROUGH THE CATHETER LUMEN AND THE DELIVERY INTRODUCER CONTAINING THE IMP-10 DEVICE EMERGED FROM THE CATHETER. SUBSEQUENT ATTEMPTS TO ADVANCE THE DEVICE WERE UNSUCCESSFUL. THEREAFTER THE CASE WAS COMPLETED USING OTHER EMBOLIC DEVICES. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED. IT WAS ADDITIONALLY STATED THAT THE TEMPERATURE INDICATOR LABEL ON THE IMP-10 DEVICE PACKAGING HAD ACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464852 ↗
• MalfunctionFeb 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN IMP-10 DEVICE WAS BEING DELIVERED USING A 7FR DESTINATION SHEATH AND A 0.035" AMPLATZ WIRE TO EMBOLIZE A LEFT SUBCLAVIAN ARTERY. AT THE BEGINNING OF DEVICE DELIVERY, THE PHYSICIAN REPORTED DIFFICULTIES ADVANCING THE PLUG THROUGH THE INTRODUCER, HOWEVER, THIS LATER GAVE WAY. DURING DEVICE DEPLOYMENT, BECAUSE THE DEVICE ANCHOR COIL DID NOT FORM AS EXPECTED, THE PHYSICIAN WITHDREW THE DESTINATION SHEATH CONTAINING THE IMP-10 DEVICE. AFTER REMOVING THE SHEATH, THE PHYSICIAN RAN A GUIDEWIRE THROUGH THE SHEATH LUMEN AND TO THEIR SURPRISE, THE DEVICE INTRODUCER EMERGED. THE IMP-10 IS SUPPLIED PRE-LOADED IN AN INTRODUCER TO FACILIATE TRANSFER INTO THE DELIVERY CATHETER/SHEATH. THEY DETERMINED THAT THE LUER HUB MAY HAVE DETACHED FROM THE INTRODUCER TUBING EARLIER AND THAT BECAUSE OF THIS, THE INTRODUCER TUBING UNKNOWINGLY ENTERED THE DESTINATION SHEATH. SUBSEQUENT FLUOROSCOPY FOUND THAT THE IMP-10 DEVICE REMAINED INSIDE THE PATIENT. THE IMP-10 ANCHOR COIL WAS REPORTED TO STRETCHED OUT AND DEPLOYED IN THE TRAJECTORY SPANNING FROM THE SUBCLAVIAN, AXILLARY AND LEFT HUMERAL ARTERY. THE FOAM PLUG COMPONENT OF THE IMP-10 DEVICE WAS IN THE BRACHIAL ARTERY. HOWEVER, NO ADVERSE EVENT TO THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456095 ↗
• MalfunctionAug 3, 2022Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  PATIENT PRESENTED WITH A LUSORIAN ARTERY ANEURYSM. AFTER DEPLOYING AN ABBOT AVPII PLUG TO THE ANEURYSM, AN IMP-10 WAS DELIVERED USING A 7FR TERUMO DESTINATION SHEATH. FIVE MINUTES AFTER DEPLOYMENT, IT WAS FOUND THE IMP-10 ANCHOR COIL HAD ELONGATED WHICH MOTIVATED THE PHYSICIANS TO REMOVE THE DEVICE BY SNARING IT TO PREVENT THE POSSIBILITY OF MIGRATION OCCURRING. SNARING THE IMP-10 CAUSED THE FOAM PLUG PORTION OF THE DEVICE TO SEPARATE FROM THE ANCHOR COIL AND MIGRATE TOWARDS THE AXILLARY ARTERY. ULTIMATELY, THE PHYSICIANS SUCCEEDED IN REMOVING THE IMP-10 RADIOPAQUE MARKER AND MUCH OF THE ANCHOR COIL AND AN ESTIMATED 80% OF THE FOAM PLUG. NO ADVERSE EVENT TO THE PATIENT OCCURRED. FOLLOWING THIS, THE CASE WAS COMPLETED USING A COMBINATION OF IMP-FX-12 AND IMP-FX-12X5 DEVICES AS WELL AS OTHER EMBOLIC DEVICES NOT MANUFACTURED BY SMM. THE PATIENT STATUS WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157566 ↗
• MalfunctionJun 7, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, THE PHYSICIAN DELIVERED AN IMP-10 TO THE LEFT OVARIAN VEIN (11 MM IN DIAMETER) TO TREAT PELVIC CONGESTION SYNDROME. AFTER WAITING 10 MINUTES AND OBSERVING NO VESSEL OCCLUSION, THE PHYSICIAN THEN COMPLETED THE CASE BY INJECTING SCLEROSANT DISTAL TO THE SITE WHERE THE PLUG WAS DELIVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950532 ↗
• MalfunctionJul 20, 2020Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  ON (B)(6) 2020, A PHYSICIAN AT PRESIDIO OSPEDALIERO SAN GIOVANNI BOSCO - NAPOLI WAS PERFORMING EMBOLIZATION OF THE HYPOGASTRIC (INTERNAL ILIAC) ARTERY PRIOR TO THE PLACEMENT OF AN AORTIC ENDOPROSTHESIS (EVAR). THE PHYSICIAN CHOSE TO USE AN IMP-10 DEVICE TO EMBOLIZE THE 4-5MM ARTERY. THE PHYSICIAN ATTEMPTED TO DELIVER TWO IMP-10 DEVICES WITH A 6FR-25CM TERUMO INTRODUCER SHEATH AND 0.035" GUIDEWIRE. NO CATHETER WAS USED. DURING THE ATTEMPTED DELIVERY OF THE FIRST IMP-10 DEVICE, THE DEVICE IMMEDIATELY BECAME STUCK AFTER TRANSFERRING FROM THE DEVICE INTRODUCER INTO THE TERUMO INTRODUCER SHEATH. THE DEVICE WAS NOT ABLE TO BE DELIVERED TO THE TARGET SIZE AND WAS REMOVED WITH THE TERUMO INTRODUCER SHEATH. DURING THE DELIVERY OF THE SECOND IMP-10 DEVICE, THE PHYSICIAN WAS ABLE TO DELIVER THE DEVICE TO THE TARGET SITE, THOUGH SOME RESISTENCE DURING DELIVERY WAS NOTED. THE DEVICE MALFUNCTION WAS REPORTED TO KARDIA, WHO IS SHAPE MEMORY MEDICAL'S DISTRIBUTOR IN ITALY AND SUBSEQUENTLY KARDIA REPORTED THIS INFORMATION THE MANUFACTURER (SHAPE MEMORY MEDICAL).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296338 ↗