Angio-SealRecalls & reported problems across all models

We found 6 models of Angio-Seal by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Apr 14, 2017 and Oct 22, 2018 — classified as 87 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (30 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. 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

Most reported Angio-Seal problems

Angio-Seal models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Angio-Seal™ VIP

  DEVICE, HEMOSTASIS, VASCULAR
  80 reports
• Angio-Seal™ Evolution™

  DEVICE, HEMOSTASIS, VASCULAR
  56 reports
• Angio-Seal™ VIP

  DEVICE, HEMOSTASIS, VASCULAR
  13 reports
• Angio-Seal™ STS Plus

  DEVICE, HEMOSTASIS, VASCULAR
  5 reports
• Angio-Seal™ Evolution™

  DEVICE, HEMOSTASIS, VASCULAR
  4 reports
• Angio-Seal™ STS Plus

  DEVICE, HEMOSTASIS, VASCULAR
  2 reports

Recent Angio-Seal adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT AN ANGIO-SEAL DEVICE WAS IMPLANTED IN HER AND A YEAR LATER AN INFECTION WAS FOUND. THE PATIENT SPENT SEVERAL WEEKS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED ON 10/16/2018: THE PATIENT WAS ADMITTED TO THE ER ON (B)(6) 2017. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION AND TWO STENTS WERE PLACED IN THE PATIENTS' CORONARY ARTERIES. THE INFECTION THEN DEVELOPED AND THE PROBLEMS BEGAN ABOUT THREE MONTHS AFTER THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE ER. THE US OF HER HEART SHOWED A "VEGETATION" AROUND THE AREA WHERE THE STENTS WERE PLACED. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE ER WITH AN INFECTION IN HER CHEST. THE INFECTION WAS IN THE PATIENT'S CHEST AND HAD MIGRATED TO HER SPINE. THE PATIENT STATED THAT THE INFECTION WAS NOT IN HER HEART AND THAT THE INFECTION HAD MIGRATED FROM THE STENTS AROUND HER HEART. THERE WERE NO COMPLICATIONS OR SIGNS OF INFECTION AT THE ACCESS SITE OR WHERE THE ANGIO-SEAL WAS DEPLOYED. THE PATIENT UNDERWENT SURGERY TO HER THORACIC SPINE, HAD CHEST TUBES INSERTED TO DRAIN THE INFECTION IN HER CHEST AND HAD A PICC LINE PLACED FOR LONG TERM IV ANTIBIOTIC THERAPY. AFTER 6 WEEKS, ONCE THE IV

  Patient problems: Unspecified Infection

  MAUDE report 7992004 ↗
• MalfunctionOct 3, 2018Activation, Positioning or Separation Problem

  DOCTOR REPORTED THE ANGIO-SEAL DEVICE FAILED TO DEPLOY. THEY ALSO NOTED A KNOWN 5% FAILURE RATE WITH THIS DEVICE. THERE WAS NO OPERATOR ERROR ISSUE, STRICTLY A FAULTY DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7929422 ↗
• MalfunctionApr 10, 2018Kinked; Material Deformation; Kinked; Material Deformation

  THE USER FACILITY REPORTED THAT THE TIP OF THE SHEATH COMPONENT OF THE ANGIO-SEAL WAS PINCHED ON THE FACING END OF THE OUTER SHEATH COMPONENT. THE DOCTOR DID NOT WANT TO USE THE PRODUCT AND ASKED FOR A NEW ANGIO-SEAL. HEMOSTASIS WAS ACHIEVED WITH A DIFFERENT ANGIO-SEAL DEVICE. THE PATIENT AND THE PROCEDURE OUTCOME WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7418689 ↗
• InjuryFeb 20, 2018Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL PORTION SEPARATED FROM THE SHEATH PORTION AFTER DEPLOYMENT OF THE FOOTPLATE. WHEN THEY WENT TO PULL BACK AND SEND THE PLUG DOWN THE DEVICE WAS CUT AND THEY MANUALLY PUSHED THE PLUG (COLLAGEN) DOWN. IT WAS REPORTED THAT HELD PRESSURE ON PATIENT FOR LITTLE BIT JUST TO BE SURE BUT COLLAGEN PLUG SEEM TO HAVE HELD. THE PATIENT CONDITION IS STABLE AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

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

  MAUDE report 7284149 ↗
• MalfunctionDec 5, 2017Split; Split

  THE USER FACILITY REPORTED THAT THE SHEATH OF THE ANGIO SEAL SPLIT UPON INSERTION WITH THE DILATOR. PATIENT WASN'T HURT BUT THE PRODUCT WAS DEFECTIVE ACCORDING TO THE FACILITY. IT WAS REPORTED THAT THE THERE WAS NO INJURY TO PATIENT AND THAT THE PATIENT CONDITION IS GOOD. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WENT WELL. ADDITIONAL INFORMATION WAS RECEIVED ON 11/16/17: IT WAS REPORTED THAT A SECOND ANGIOSEAL DEVICE WAS USED IN ORDER TO ACHIEVE HEMOSTASIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084314 ↗
• MalfunctionDec 5, 2017Difficult or Delayed Positioning; Physical Resistance; Difficult or Delayed Positioning; Physical Resistance

  THE USER FACILITY REPORTED DIFFICULTIES WITH THE INVOLVED ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR USED AN ANGIO-SEAL EVOLUTION 6FR TO PERFORM A LHC DIAGNOSTIC ANGIOGRAPHY PROCEDURE FOR A CAD. DURING THE CLOSURE OF THE PUNCTURE, AND AFTER THE DOCTORS DEPLOYED THE ANCHOR, HE PULLED THE DEVICE HANDLE INTO THE FULL REAR POSITION. WHEN THE DOCTOR PRESSED THE SUTURE RELEASE BUTTON, AND PULLED BACK THE SUTURE CABLE, HE ENCOUNTERED A LOT OF TENSION AND RESISTANCE DURING THE PULLBACK. NO OUTSIDE PRESENCE OF THE ANCHOR OR COLLAGEN WAS OBSERVED. THERE WAS NO INFECTIOUS DISEASE. HEMOSTASIS WAS ACHIEVED, AND NO MANUAL PRESSURE WAS REQUIRED. THE PATIENT WAS REPORTED TO BE WELL AND WAS ALREADY DISCHARGED. THERE WERE NO REPORTED COMPLICATIONS WITH THE PROCEDURE OUTCOME. A FEMORAL INTRODUCES AND A REGULAR GUIDEWIRE WERE USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7082741 ↗
• MalfunctionNov 30, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THE DEVICE SHEATH FELL APART UPON APPLICATION. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO OTHER DEVICES OR EQUIPMENT BEING USED WITH THE REPORTED DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072057 ↗
• InjuryNov 30, 2017Detachment Of Device Component; Detachment Of Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 8, 2017: IT WAS REPORTED THAT HEMOSTASIS WAS NOT ACHIEVED WITH THE ANGIOSEAL. THEY WERE ABLE TO HOLD PRESSURE AND THE PATIENT SUCCESSFULLY STOPPED BLEEDING POST-OP. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS CONFIRMED THAT THEY PHYSICALLY SAW THE SAMPLE AND THAT THE ANCHOR IS STILL IN THE ANGIOSEAL SHEATH. THEREFORE, IT WAS NOT LEFT IN THE PATIENT. IT WAS REPORTED THAT THE COLLAGEN WAS NOT TAMPED DOWN AND DEPLOYED DUE TO NOT EXISTING THE SHEATH UPON APPLICATION.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 7071154 ↗
• MalfunctionNov 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL ACCESS SHEATH CAME APART. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071150 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL ACCESS SHEATH CAME APART. ADDITIONAL INFORMATION WAS RECEIVED ON 11/8/2017. THE SHEATH OF THE ANGIOSEAL CAME APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068335 ↗
• MalfunctionNov 20, 2017Bent; Bent

  THE USER FACILITY REPORTED THE TIP OF THE INVOLVED ANGIO-SEAL DEVICE WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: THE ANGIO-SEAL WAS BENT COMING OUT OF THE PACKAGE. THE LAB DID NOT USE THE DEVICE ON PATIENT, THEY DECIDED TO USE ANOTHER. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017. HEMOSTASIS WAS ACHIEVED BY THE SECOND DEVICE USED. THE PATIENT PROCEDURE WAS SUCCESSFUL, AND HEMOSTASIS WAS ACHIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046522 ↗
• InjuryNov 16, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE FOOTPLATE AND THE DEVICE WAS KINKED AND WOULD NOT ADVANCE THROUGH THE ARTERIOTOMY LOCATOR. THE PHYSICIAN THEN DID MANUAL PRESSURE. NOTHING WAS DEPLOYED IN THE PATIENT WITH REGARD TO THE ANGIOSEAL DEVICE. THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE OUTCOME WAS REPORTED TO BE FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037110 ↗
• InjuryNov 14, 2017Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WITH THE INVOLVED ANGIO-SEAL EVOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR REPORTED THAT THE DEVICE DID NOT DEPLOY CORRECTLY. IT WAS REPORTED THAT BLOOD LOSS WAS LESS THAN 250CC. AN ALTERNATE EVOLUTION DEVICE WAS USED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS REPORTED TO BE A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 8, 2017. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE AND THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7029827 ↗
• MalfunctionNov 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED NO/INADEQUATE BLOOD RETURN WHEN USING THE ANGIO-SEAL VIP DEVICE DURING AN INTERVENTIONAL CATHETERIZATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: CASE WAS COMPLETE EXCEPT FOR CLOSURE DEVICE. ONCE THE ARTERIOTOMY LOCATOR WAS INSERTED INTO THE PATIENT, THERE WAS NO VISIBLE BLOOD FLASH. SO THE DEVICE WAS PULLED OUT AND ANOTHER ANGIO-SEAL WAS OPENED. THE SECOND ANGIO-SEAL WAS SUCCESSFUL. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL. ADDITIONAL INFORMATION WAS REPORTED ON 10/17/2017: BLOOD LOSS WAS REPORTED TO BE MINIMAL. THE PATIENT WAS REPORTED TO BE FINE AND STABLE. NO OTHER DEVICES WERE USED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7016889 ↗
• MalfunctionNov 1, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WITH THE ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE REPORTER MENTIONED THAT PHYSICIANS ARE STATING THE BUTTON THAT RELEASES THE SUTURE SO THAT IT IS VISIBLE TO CUT IS MALFUNCTIONING. PHYSICIANS STATE THAT THE BUTTON DOES NOT DEPRESS AND THEY HAVE TO PULL VERY HARD TO EXPOSE THE SUTURE AFTER SEVERAL ATTEMPTS AT DEPRESSING THE BUTTON. IT WAS REPORTED THAT HEMOSTASIS WAS OBTAINED. THE ISSUE ALLEGEDLY LIES WITHIN THE BUTTON RELEASE. IT WAS REPORTED THAT THE PATIENT IS STABLE. THE PROCEDURE OUTCOME WAS REPORTED ADEQUATE. ADDITIONAL INFORMATION WAS RECEIVED ON 10/11/17. HEMOSTASIS WAS ACHIEVED BY THE DEVICE. THE PATIENT WAS NOT EFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6994492 ↗

Other St. Jude Medical Cardiovascular Division products

• BRK4 models · 177 reports
• BRK-16 models · 102 reports
• Pacel9 models · 52 reports
• Supreme16 models · 43 reports
• Safire5 models · 31 reports
• Livewire10 models · 30 reports