Angio-Seal™ VIP (REF 610131)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067002853), received between Apr 14, 2017 and Apr 10, 2018 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 3, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL OPENED WAS NOT USED DUE TO THE DILATOR BEING DAMAGED OUT OF THE PACKAGE. THE VERY DISTAL TIP. ANOTHER ANGIOSEAL WAS OPENED AND USED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 9/8/2017: IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PACKAGE AND THEY NOTICED THE DISTAL TIP WAS DAMAGED. THEY THEN OPENED A NEW DEVICE AND ACHIEVED HEMOSTASIS. HEMOSTASIS WAS ACHIEVED BY HOLDING PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6911052 ↗
• InjuryOct 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL DEVICE COLLAGEN REMAINED OUTSIDE THE BODY AND HAD TO BE PUT UNDER THE SKIN. IT WAS REPORTED THAT THE END OF THE DEPLOYMENT SHEATH WAS CRIMPED UPON REMOVAL. IT WAS REPORTED THAT THE PATIENT CONDITION WAS GOOD. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 9/8/17: IT WAS REPORTED THAT HEMOSTASIS WAS ACHIEVED BY HOLDING PRESSURE. WHEN THEY FIRST TRIED TO TUCK THE COLLAGEN UNDER THE SKIN IT BEGAN BLEEDING. PRESSURE WAS HELD, AND THEN THEY TUCKED THE COLLAGEN UNDER AFTER HEMOSTASIS HAD BEEN ACHIEVED. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THEY NOTICED THE DISTAL TIP DAMAGE. A NEW DEVICE WAS OPENED. AN 8FR SHEATH WAS USED.

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

  MAUDE report 6910901 ↗
• InjuryAug 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE BLACK COMPACTION MARKER ON THE ANGIO-SEAL VIP WAS NOT VISUALIZED DURING DEPLOYMENT, WHICH LED TO OVERTIGHTENING OF THE DEVICE. PATIENT WAS HAVING A CEREBRAL ANEURYSM COILING PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: DURING DEPLOYMENT OF THE ANGIO-SEAL VIP, THE BLACK COMPACTION MARKER WAS NOT EASILY VISIBLE, WHICH THE PHYSICIAN BELIEVED LED TO OVERTIGHTENING OF THE DEVICE. THE DEVICE WAS DEPLOYED. LATER THAT EVENING THE PATIENT BEGAN BLEEDING AND DEVELOPED AN ABDOMINAL WALL HEMATOMA. THE HEMATOMA WAS COMPRESSED AND A FEMOSTOP WAS APPLIED TO THE PUNCTURE SITE. THE PATIENT BLED AGAIN SOMETIME LATER, AND AGAIN A THIRD TIME. THE PATIENT WENT INTO CARDIAC ARREST THE THIRD TIME SHE BLED. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS AND TRANSFUSIONS DUE TO BLOOD LOSS. SHE WAS TAKEN TO SURGERY AND A HOLE WAS FOUND AT THE ARTERIOTOMY SITE WITH NO EVIDENCE OF THE ANGIO-SEAL. SOMETIME AFTER THE SURGERY THE PATIENT HAD A STROKE. SHE HAS COMPLETED REHAB FOR HER STROKE AND HAS RETURNED TO THE HOSPITAL FOR THREE ADDITIONAL OPERATIONS TO REMOVE RESIDUAL BLOOD FROM HER ABDOMINAL WALL HEMATOMA. PHYSICIAN IS A LONG TIME EXPERIENCED USER

  Patient problems: Blood Loss; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6810730 ↗
• MalfunctionAug 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE ARTERIOTOMY LOCATOR RESISTANCE AS INSERTING INTO INSERTION SHEATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: VERIFIED INSERTION SHEATH WAS PLACED CORRECTLY. THEY VERIFIED NO OBSTRUCTION VISIBLE OTHERWISE; THEN ATTEMPTED TO INSERT ARTERIOTOMY LOCATOR AGAIN WITH NO SUCCESS AND NOTICED THE INSERTION SHEATH BECAME KINKED. DIDN'T DEPLOY THIS DEVICE; GRABBED ANOTHER UNIT AND SUCCESSFULLY DELIVERED. THE PROCEDURE OUTCOME WAS SUCCESSFUL AND THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6770696 ↗
• MalfunctionAug 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE DOCTOR HAS AN ANGIO-SEAL "MISFIRE". THE PATIENT WAS CLOSED WITH ANGIO-SEAL AND NEEDED A SURGEON ADDRESS AN ISSUE SOMETIME WITHIN THE NEXT 24HRS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6767240 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN RESPONSE TO USER FACILITY MEDWATCH REPORT # (B)(4) WHICH WAS RECEIVED FROM THE (B)(4) ON JULY 7, 2017. THE EVENT DESCRIPTION STATES THAT THE WIRE AND SHEATH WERE PULLED BACK TO THE LEVEL OF THE IPSILATERAL ILIAC ARTERY AND AN IPSILATERAL OBLIQUE ARTERIOGRAM WAS OBTAINED WHICH REVEALED ADEQUATE CALIBER AND LOCATION OF THE ACCESS SITE FOR PLACEMENT OF A CLOSURE DEVICE. AN 8 FRENCH ANGIO-SEAL CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED. EXCELLENT HEMOSTASIS WAS OBTAINED. ALMOST TWO WEEKS LATER, SURGERY PROCEDURAL NOTE MORE PROCEDURE FINDINGS: EXTREME PHLEGMON ALONG ANTERIOR SURFACE OF RIGHT CFA. RIGHT ILIOFEMORAL ENDARTERECTOMY WITH REMOVAL OF FOREIGN BODY AND INFECTED ARTERIAL WALL WITH CORMATRIX ECM RECONSTRUCTION. THE ORIGINAL INTENDED PROCEDURE PERFORMED WAS ON (B)(6)2017. ULTRASOUND-GUIDED PUNCTURE OF THE RIGHT COMMON FEMORAL ARTERY WITH CATHETERIZATION OF THE ABDOMINAL AORTA AND PELVIC ARTERIOGRAM. SELECTIVE CATHETERIZATION OF THE LEFT BRACHIAL ARTERY FROM THE RIGHT FEMORAL ACCESS. BALLOON ANGIOPLASTY AND STENTING WAS DONE TO THE LEFT SUBCLAVIAN ARTERY USING A 7 X 19 MM GORE V BX DISTALLY AND A 10 X 29 MM GORE V BX PROXIMALLY IN AN OVERLAPPING FASH

  Patient problems: Unspecified Infection

  MAUDE report 6766724 ↗
• InjuryJul 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THE ANCHOR NOT SETTING ON THE ANGIO-SEAL DEVICE DURING A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THIS WAS A BILATERAL ILIAC CASE WITH FEMORAL ACCESS BOTH ON THE LEFT SIDE; ON THE LEFT SIDE ONE DEVICE WAS KINKED UPON INSERTION AND IT IS AVAILABLE TO BE RETURNED FOR EVALUATION; THE SECOND DEVICE WAS INSERTED AND PROPER DEPLOYMENT STEPS WERE FOLLOWED, BUT THE ANCHOR DID NOT SET AND THE DEVICE FAILED; THE TECH CUT THE STRING AND THE ABSORBABLE COMPONENTS WERE LEFT INSIDE THE PATIENT; AT THE INITIAL ULTRASOUND NO BLOCKAGES FROM THE ANCHOR WERE DETECTED AND A PULSE WAS FOUND ON THE FOOT; THE REASON SHE THOUGHT THE ANCHOR DETACHED WAS BECAUSE THE SEAL FAILED; THERE IS NO EVIDENCE THAT THE ANCHOR ACTUALLY DID DETACH; THE COLLAGEN WAS TAMPED DOWN; PRESSURE HAD TO BE HELD TO STOP THE BLEEDING; THEY WERE STILL CONCERNED THAT THE ANCHOR WAS IN THE PATIENT; THERE WAS NO OCCLUSION CAUSED BY THE FAILED DEVICE; THE ANCHOR NOT SETTING WAS AFTER THE FIRST DEVICE BENT ON INSERTION ON THE LEFT SIDE; THERE WERE NO ISSUES REPORTED FOR THE OUTCOME OF THE PROCEDURE; THE BLOOD LOSS WAS LESS THAN 250 CC'S; AND POST PROCEDURE THE PATIENT HAD NO ISSUE

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

  MAUDE report 6684151 ↗
• InjuryJun 30, 2017Kinked; Kinked

  THE USER FACILITY REPORTED A KINK IN THE ANGIO-SEAL DEVICE DURING A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THIS WAS A BILATERAL ILIAC CASE WITH FEMORAL ACCESS BOTH ON THE LEFT SIDE; ON THE LEFT SIDE ONE DEVICE WAS KINKED UPON INSERTION AND IT IS AVAILABLE TO BE RETURNED FOR EVALUATION; THE SECOND DEVICE WAS INSERTED AND PROPER DEPLOYMENT STEPS WERE FOLLOWED, BUT THE ANCHOR DID NOT SET AND THE DEVICE FAILED; PRESSURE HAD TO BE HELD TO STOP THE BLEEDING; THE PHYSICIAN THEN CHECKED THE LOWER LEG WITH AN ULTRASOUND TO MAKE SURE THE FLOW HAD NOT BEEN SHUT DOWN BY A LOOSE ANCHOR, AND THERE WAS FLOW TO THE FOOT AND A PULSE WAS FOUND; THERE WAS NO OCCLUSION CAUSED BY THE FAILED DEVICE; THE PHYSICIAN IS STILL CONCERNED THAT THE ANCHOR WAS IN THE PATIENT; THERE WERE NO ISSUES REPORTED FOR THE OUTCOME OF THE PROCEDURE; THE BLOOD LOSS WAS LESS THAN 250CC'S; AND POST PROCEDURE THE PATIENT HAD NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6682357 ↗
• InjuryMay 22, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE FOOTPLATE AND COLLAGEN PULLED OUT WHEN THE ANGIO SEAL DEVICE WAS DEPLOYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PATIENT WAS IN FOR A HEART CATHETERIZATION PROCEDURE USING A 7 FRENCH SHEATH; THE ANGIO SEAL DEVICE DEPLOYED AND THE FOOTPLATE AND COLLAGEN PULLED OUT UPON DEPLOYMENT; AND THERE WAS NO REPORTED BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 05/10/2017. HEMOSTASIS WAS ACHIEVED BY HOLDING MANUAL PRESSURE FOR TWENTY MINUTES. BLOOD LOSS WAS REPORTED TO BE MINIMAL, LESS THAN 250 CC. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6582760 ↗
• InjuryApr 14, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL VIP DEVICE SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR TRIED TO DEPLOY THE ANGIOSEAL AND WHEN THE DOCTOR WENT IN WITH THE DEVICE AND WAS PLACING FOR BLOOD RETURN, HE COULD NOT ADVANCE AND PULL BACK EASY SO HE PULLED OUT THE ANGIOSEAL AND PUT THE SHEATH IN AND SAW ONLY AN INCH COME BACK OUT AND SAW PIECES OF IT; IT WAS REPORTED THAT IT WAS THE OUTER SHEATH THAT WAS DISLODGED; IT WAS REPORTED THAT THEY FOUND A FEW PIECES BUT NOT ALL; THE PATIENT HAD AN ULTRASOUND AND CT SCAN WHICH CONFIRMED PRESENCE OF A FOREIGN OBJECT IN THE CFA AND WILL BE SURGICALLY REMOVED; THE PATIENT IS SCHEDULED FOR SURGERY. ADDITIONAL INFORMATION WAS REPORTED ON (B)(6) 2017: THE DOCTOR TRIED TO DEPLOY THE ANGIO-SEAL. WHEN HE WENT IN WITH THE DEVICE AND WAS PLACING FOR BLOOD RETURN HE HAD DIFFICULTY. HE HEARD A "CRUNCH" GOING IN. WHEN HE PULLED THE ANGIO-SEAL OUT, THE SHEATH WAS COMPLETELY BROKEN OFF BACK TO THE "AL" LETTER INDICATORS ON THE SHEATH. FRAGMENTS WERE NOTED ON THE PATIENTS' SKIN. NO VISIBLE SHEATH COMPONENTS WERE STICKING OUT OF THE SKIN INCISION. FOUND A FEW FRAGMENTS BUT NOT ALL. THE DOCTOR KEPT THE WIRE IN THE

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 6493061 ↗