ANGIO-SEAL 610121Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00389701011851), received between Mar 6, 2018 and May 12, 2021 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EXPIRED ANGIO-SEAL WAS IMPLANTED IN A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021: PROCEDURE PERFORMED WAS A LEFT HEART CATHETERIZATION (LHC) PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH IMPELLA SUPPORT. THE CIRCULATOR NURSE STEPPED OUT OF THE ROOM, AND THE OTHER NURSE WENT AND PULLED AN ANGIO-SEAL DEVICE OUT OF THE PAR EXCELLENCE SUPPLY CABINET. THE DEVICE WAS HANDED TO THE SCRUB TECH AND THE NURSE WENT BACK TO MIXING THE MEDICATION DRIP. AFTER IT WAS IMPLANTED IN THE PATIENT'S ARTERY IS WHEN IT WAS BEING ENTERED IN THE DOCUMENT SYSTEM WAS WHEN IT WAS NOTED THAT THE ANGIO-SEAL DEVICE WAS EXPIRED. THE PROCEDURE SHEATH SIZE USED WAS A 7FR. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. HEMOSTASIS ACHIEVED SUCCESSFULLY. THE PATIENT HAS NOT SHOWED ANY COMPLICATIONS SINCE THE IMPLANT. THE PATIENT WAS IN STABLE CONDONATION. THERE HAVE BEEN NO INFECTIONS REPORTED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814395 ↗
• InjuryAug 10, 2020Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE INVOLVED 8FR ANGIO-SEAL DEVICE WAS ATTEMPTED POST 7FR DESTINATION REMOVAL. THE CATH LAB REPORTS THAT THE ANCHOR DID NOT DEPLOY OUT OF ANGIO-SEAL SHEATH. THE RT FOLLOWED CORRECT STEPS AND PROCEEDED TO SEAL; UPON THE PULL BACK OF THE ANGIO-SEAL SYSTEM, THE ENTIRE UNIT CAME OUT OF THE BODY. IT WAS NOTICED AFTER SITE WAS CONTROLLED THAT THE ANCHOR WAS IN THE EDGE OF THE ANGIO-SEAL SHEATH. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS SUCCESSFUL; HOWEVER, FAILED CLOSURE. ADDITIONAL INFORMATION WAS RECEIVED ON 21JUL2020. THE PROCEDURE PERFORMED PRIOR TO USE OF THE ANGIO-SEAL DEVICE WAS AN ATHERECTOMY OF LEFT LEG. A 7FR DESTINATION WAS USED DURING THE PROCEDURE. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. EVERYTHING WEN SMOOTH UNTIL CLOSURE. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUL2020. THE FOOTPLATE NEVER CAME OUT OF SHEATH WHILE DEPLOYING. THE ANGIO-SEAL WAS CUT TO CONFIRM THAT THE FOOTPLATE WAS IN THE SHEATH AND NOT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384173 ↗
• InjuryJul 23, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THE INVOLVED 8FR ANGIO-SEAL DEVICE FAILED. THE PATIENT'S CONDITION WAS STABLE, POSITIVE PATIENT OUTCOME. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 08JUL2020. THE PROCEDURE BEING PERFORMED WAS AN ABDOMINAL ANGIOGRAM WITH ANGIOPLASTY AND STENT PLACEMENT. A 7FR SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE DEVICE FELT LIKE THE PLUG DID NOT CATCH OR DISLODGED. WHILE HOLDING THE DEVICE TAUGHT AND PUSHING THE GREEN PLASTIC TUBE DOWN; IT SUDDENLY FELT LIKE THE DEVICE MOVED (LOOSED UP AND GAVE MORE STRING). AN 180CM ANGLED GLIDE WIRE WAS USED. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE.

  Patient problems: No Patient Involvement

  MAUDE report 10313494 ↗
• MalfunctionMar 2, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE 8FR ANGIO-SEAL DEVICE HAD AN UNKNOWN ISSUE IN THE PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 12FEB2020. THE DEVICE WAS NOT USED AS IT CAME OUT OF THE PACKAGE KINKED.

  Patient problems: No Patient Involvement

  MAUDE report 9776405 ↗
• MalfunctionNov 18, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5090206. THE EVENT DESCRIPTION STATES: ANGIO-SEAL DEVICE FAILED TO DEPLOY CORRECTLY IN ARTERY.

  Patient problems: No Information

  MAUDE report 9334529 ↗
• InjuryOct 17, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT A FAILED DEPLOYMENT OF THE INVOLVED ANGIO-SEAL 8FR STS DEVICE. THE PATIENT CAME IN FOR A CEREBRAL THROMBECTOMY AND AFTER THE CASE THE FAILED DEPLOYMENT OF THE ANGIO-SEAL RESULTED IN PATIENT GOING TO THE OR TO GET THE PLASTIC OUT OF THE COMMON FEMORAL ARTERY (CFA). THE OR STAFF STATED THAT PIECES OF PLASTIC WERE IN THE COMMON FEMORAL; MIXED IN WITH A CLOT. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS CONDITION WAS STABLE AND WAS REPORTED TO STILL BE IN THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED ON 23SEP2019. THE PLASTIC THAT WAS REMOVED FROM THE PATIENT IS NOT KNOWN, THE PHYSICIAN DID NOT KNOW WHAT THE PLASTIC WAS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9201887 ↗
• MalfunctionOct 7, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT TWO ANGIO-SEAL DEVICES WOULD NOT GO IN FOR THE FOOTPLATE TO PULL BACK SO THE WHOLE THING CAME OUT. ON THE THIRD ANGIO-SEAL DEVICE, IT WORKED. TWO OF THE DEVICES HAD AN ISSUE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED 13 SEPTEMBER 2019: THE TWO DEVICES WERE USED DURING THE SAME PROCEDURE AND WAS THE SAME PATIENT. THE PATIENT WAS HAVING A PERIPHERAL PROCEDURE USING A 7FR PROCEDURAL SHEATH. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161168 ↗
• MalfunctionOct 7, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT TWO ANGIO-SEAL DEVICES WOULD NOT GO IN FOR THE FOOTPLATE TO PULL BACK SO THE WHOLE THING CAME OUT. ON THE THIRD ANGIO-SEAL DEVICE, IT WORKED. TWO OF THE DEVICES HAS AN ISSUE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED 13 SEPTEMBER 2019: THE TWO DEVICES WERE USED DURING THE SAME PROCEDURE AND WAS THE SAME PATIENT. THE PATIENT WAS HAVING A PERIPHERAL PROCEDURE USING A 7FR PROCEDURAL SHEATH. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161165 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE PLASTIC TIP THAT HOUSES THE INTRA-ARTERIAL FOOTPLATE WAS DISLODGED BEFORE INSERTING IT INTO THE ANGIO-SEAL SHEATH. THIS HAPPENED TWICE CAUSING THE FOOTPLATE TO BE EXPOSED AND FLOPPY BEFORE INSERTING. THE THIRD ANGIO-SEAL DEVICE WAS USED PROPERLY AND WORKED PER USUAL. THE FIRST TWO DEVICES WERE NOT INSERTED INTO THE PATIENT. THE IR MANAGER AND THE DOCTOR BOTH STATED THIS WAS PROBABLY DUE TO USER ERROR. BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss

  MAUDE report 9125765 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE PLASTIC TIP THAT HOUSES THE INTRA-ARTERIAL FOOTPLATE WAS DISLODGED BEFORE INSERTING IT INTO THE ANGIO-SEAL SHEATH. THIS HAPPENED TWICE CAUSING THE FOOTPLATE TO BE EXPOSED AND FLOPPY BEFORE INSERTING. THE THIRD ANGIO-SEAL DEVICE WAS USED PROPERLY AND WORKED PER USUAL. THE FIRST TWO DEVICES WERE NOT INSERTED INTO THE PATIENT. THE IR MANAGER AND THE DOCTOR BOTH BELIEVE THIS WAS PROBABLY DUE TO USER ERROR. BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss

  MAUDE report 9125764 ↗
• MalfunctionAug 28, 2019Separation Problem; Separation Problem

  THE USER FACILITY REPORTED THAT AN ISSUE WITH THE INVOLVED ANGO-SEAL DEVICE. A SECOND ANGIO-SEAL DEVICE WAS USED, AND EVERYTHING WENT WELL. ADDITIONAL INFORMATION WAS RECEIVED ON 20AUG2019. THE PROCEDURE WAS AN ENDOSTENT. THERE WAS NO ISSUE WITH THE PATIENT WHEN THE ANGIOS-SEAL WAS OPENED; IT WAS NOT TOGETHER AND WOULD NOT GO BACK TOGETHER. THEREFORE, A SECOND HAD TO BE OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8942173 ↗
• MalfunctionAug 14, 2019Component Missing; Component Missing

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE COLLAGEN PLUG, AND THE ANCHOR WERE COMPLETELY HANGING OUT OF THE CARRIER TUBE. THERE WAS NO BYPASS TUBE AT ALL, IT WAS COMPLETELY MISSING FROM THE DEVICE. THIS DEVICE WAS NOT USABLE AT ALL AND ANOTHER 8FR ANGIO-SEAL UNIT HAD TO BE OPENED. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT'S CONDITION WAS FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 02AUG2019. THE TYPE OF PROCEDURE WAS A PERIPHERAL ARTERY DISEASE CASE WHERE THEY WERE TREATING A LESION IN THE SUPERFICIAL FEMORAL ARTERY USING GROIN ACCESS. THE DOCTOR USED A JETSTREAM 7F DEVICE DURING THE PROCEDURE, THAT IS WHY THEY WERE USING AN 8FR ANGIO-SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892981 ↗
• InjuryMay 31, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE DID NOT SEAL CORRECTLY. THE PATIENT IS FINE, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED MAY 16, 2019: THE PHYSICIAN STATED THAT WHEN TAMPING DOWN TO DEPLOY, IT DIDN'T FEEL THE SAME AS IT NORMALLY WOULD. AN 8FR SHEATH WAS USED DURING THE CASE. MANUAL COMPRESSION WAS APPLIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660397 ↗
• MalfunctionApr 19, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT SOMETHING HAPPENED TO THE TIP OF THE ANGIO-SEAL DEVICE TO NOT ALLOW IT TO DEPLOY. WHEN THEY WENT TO DEPLOY THE END IT WOULD NOT DEPLOY. HEMOSTASIS WAS ACHIEVED WITH A SECOND ANGIO-SEAL DEVICE, AND THE PROCEDURE OUTCOME WAS REPORTED TO BE FINE. THERE WAS NO PATIENT INJURY, AND THERE WAS NO MEDICAL INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2019. THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE WHEN OPENED OR DURING ARTERIAL ACCESS. A 7FR SHEATH WAS USED. PROCEDURE FOR PATIENT PRIOR TO THE CLOSURE WAS A LOWER EXTREMITY ANGIOGRAM. DURING THE FINAL STEP OF DEPLOYMENT IT WOULD NOT WORK FOR CLOSURE. IT SEEMED LIKE THE PIECE AT THE TIP THAT SHOULD HAVE CLOSED THE ARTERY, WAS MISSING THE DISK (ANCHOR). THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531967 ↗
• MalfunctionMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THEY USED FOUR DIFFERENT ANGIO-SEAL STS 8FR DEVICES. THE CUSTOMER HAD ISSUES WITH THE COLLAGEN/BYPASS TUBE STAYING IN PLACE. THEY DID NOT ATTEMPT TO PLACE THE FIRST THREE DEVICES IN THE PATIENT. THE CUSTOMER SAID THE DEVICE WAS COMING APART NEAR THE COLLAGE/BYPASS TUBE. THE CUSTOMER USED THE FOURTH DEVICE ON THE PATIENT. UPON DEPLOYMENT THE CUSTOMER NOTICED THAT THE DEVICE WAS COMING APART AND DID NOT HAVE GOOD HEMOSTASIS. THE CUSTOMER HELD PRESSURE ON THE PATIENT AND THAT CONTROLLED THE BLEEDING. ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. MANUAL COMPRESSION WAS USED TO CLOSE THE ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553880 ↗
• InjuryMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THEY USED FOUR DIFFERENT ANGIO-SEAL STS 8FR DEVICES. THE CUSTOMER HAD ISSUES WITH THE COLLAGEN/BYPASS TUBE STAYING IN PLACE. THEY DID NOT ATTEMPT TO PLACE THE FIRST THREE DEVICES IN THE PATIENT. THE CUSTOMER SAID THE DEVICE WAS COMING APART NEAR THE COLLAGE/BYPASS TUBE. THE CUSTOMER USED THE FOURTH DEVICE ON THE PATIENT. UPON DEPLOYMENT THE CUSTOMER NOTICED THAT THE DEVICE WAS COMING APART AND DID NOT HAVE GOOD HEMOSTASIS. THE CUSTOMER HELD PRESSURE ON THE PATIENT AND THAT CONTROLLED THE BLEEDING. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. MANUAL COMPRESSION WAS USED TO CLOSE THE ARTERY.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 7553879 ↗
• MalfunctionMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THEY USED FOUR DIFFERENT ANGIO-SEAL STS 8FR DEVICES. THE CUSTOMER HAD ISSUES WITH THE COLLAGEN/BYPASS TUBE STAYING IN PLACE. THEY DID NOT ATTEMPT TO PLACE THE FIRST THREE DEVICES IN THE PATIENT. THE CUSTOMER SAID THE DEVICE WAS COMING APART NEAR THE COLLAGE/BYPASS TUBE. THE CUSTOMER USED THE FOURTH DEVICE ON THE PATIENT. UPON DEPLOYMENT THE CUSTOMER NOTICED THAT THE DEVICE WAS COMING APART AND DID NOT HAVE GOOD HEMOSTASIS. THE CUSTOMER HELD PRESSURE ON THE PATIENT AND THAT CONTROLLED THE BLEEDING. ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. MANUAL COMPRESSION WAS USED TO CLOSE THE ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553876 ↗
• MalfunctionMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THEY USED FOUR DIFFERENT ANGIO-SEAL STS 8FR DEVICES. THE CUSTOMER HAD ISSUES WITH THE COLLAGEN/BYPASS TUBE STAYING IN PLACE. THEY DID NOT ATTEMPT TO PLACE THE FIRST THREE DEVICES IN THE PATIENT. THE CUSTOMER SAID THE DEVICE WAS COMING APART NEAR THE COLLAGE/BYPASS TUBE. THE CUSTOMER USED THE FOURTH DEVICE ON THE PATIENT. UPON DEPLOYMENT THE CUSTOMER NOTICED THAT THE DEVICE WAS COMING APART AND DID NOT HAVE GOOD HEMOSTASIS. THE CUSTOMER HELD PRESSURE ON THE PATIENT AND THAT CONTROLLED THE BLEEDING. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. MANUAL COMPRESSION WAS USED TO CLOSE THE ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553875 ↗
• MalfunctionMay 22, 2018Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED THAT THE DOCTOR STATED THE INVOLVED ANGIO-SEAL DEVICE DID NOT DEPLOYED. THERE WAS NO BLOOD LOSS AND THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE OUTCOME WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7534016 ↗
• InjuryMar 6, 2018Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE PLUG WOULD NOT TRACK INTO THE ARTERIOTOMY LOCATOR. IT WAS REPORTED THAT AFTER REPEATED ATTEMPTS TO PASS THE PLUG IT WAS DECIDED TO PULL EVERYTHING OUT AND HOLD MANUAL PRESSURE. IT WAS REPORTED THAT ALTHOUGH THE CLOSURE FAILED, THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 2/15/2018. THE ANGIO-SEAL SHEATH (ARTERIOTOMY LOCATOR) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL ARTERY WITHOUT ISSUE. WHEN THE PLUG WAS INSERTED AND THE DEPLOYMENT CATHETER WAS ATTEMPTED TO BE TRACKED THROUGH THE SHEATH, IT WOULD NOT GO. IT WAS REPORTED THAT WHEN STANDING NEXT TO THE DOCTOR WHEN HE WAS DEPLOYING, IT WOULD NOT TRACK. IT WAS REPORTED THAT WHEN THE DOCTOR WAS APPLYING A LOT OF FORCE ATTEMPTING TO PUSH IT THROUGH, AFTER A FEW SECONDS IT WAS RECOMMENDED THAT THE DOCTOR PULL THE SHEATH AND HOLD MANUAL PRESSURE. IT WAS REPORTED THAT WHEN OBSERVING THE SHEATH ONCE IT WAS PULLED, THE FOOTPLATE HAD NOT EXITED THE DISTAL PART OF THE SHEATH. IT WAS REPORTED THAT THE DOCTOR'S TECHNIQUE APPEARED TO BE TEXTBOOK. IT WAS REPORTED THIS DID NOT CAUSE ANY ADDITIONAL BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 7318093 ↗