Surfacer Inside-Out Access Catheter System 600200/ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00860003451601), received between Jan 26, 2021 and Jul 25, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE PATIENT EXPERIENCED AN ARTERIAL PERFORATION REQUIRING INTERVENTION AND ALSO SUFFERED A STROKE POST PROCEDURE DUE TO PHYSICIAN FAILURE TO PROPERLY ANTICOAGULANT THE PATIENT. THE PHYSICIAN STATES THAT THE DEVICE WAS SUCCESSFULLY ADVANCED FROM THE PATIENT'S RIGHT FEMORAL VEIN TO THE SITE OF THE OCCLUSION IN THE SVC. THE DEVICE WAS THEN ADVANCED THROUGH THE TARGETED OCCLUSION, AND THE TIP OF THE DEVICE WAS ADVANCED SUPERIOR TO THE RIGHT CLAVICLE. THE TIP OF THE DEVICE AND THE EXIT SITE TARGET WERE CORRECTLY ALIGNED UNDER FLUOROSCOPY AND THE NEEDLE WIRE WAS ADVANCED AND EXTERIORIZED WITH THE ASSISTANCE OF AN #11 BLADE AND A PAIR OF HEMOSTATS. THE PEEL AWAY SHEATH WAS THEN ADVANCED OVER THE WIRE TO THE PATIENT. HEMOSTATS WERE PLACED AT THE PROXIMAL END OF THE SHEATH CLAMPING THE WIRE IN PLACE. THE PHYSICIAN THEN LOCKED THE WIRE IN PLACE ON THE DEVICE AND PROCEEDED TO PULL THE SHEATH INSIDE THE PATIENT. THE PHYSICIAN THEN ADMINISTERED CONTRAST THROUGH THE SHEATH AND OBSERVED VASCULAR EXTRAVASATION DUE TO PERFORATION OF THE ARTERY. THE DEVICE WAS THEN REMOVED FROM THE PATIENT ENTIRELY AND THE INTERVENTIONAL CARDIOLOGY TEAM WAS URGENTLY CALLE

  Patient problems: Perforation of Vessels

  MAUDE report 17393786 ↗
• InjuryMay 4, 2023Use of Device Problem; Obstruction of Flow

  A 71 YR. OLD, AFRICAN-AMERICAN FEMALE WITH END STAGE KIDNEY DISEASE (ESKD) PRESENTED WITH A TYPE 3 OCCLUSION OF THE SUPERIOR VENA CAVA (SVC) AND LEFT BRACHIOCEPHALIC STENT IN PLACE. THE SURFACER SYSTEM PROCEDURE WAS UTILIZED TO OBTAIN CENTRAL VENOUS ACCESS AND FACILITATE CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM. FOLLOWING THE SURFACER PROCEDURE, PLACEMENT OF A TUNNELED DIALYSIS CATHETER WAS PLANNED FOR SUBSEQUENT PLACEMENT OF THE HERO GRAFT FOR HEMODIALYSIS TREATMENT. USING STANDARD SELDINGER TECHNIQUE, RIGHT FEMORAL VEIN ACCESS WAS ACHIEVED. AN 0.035MM WIRE WAS INSERTED FOLLOWED BY A DIAGNOSTIC CATHETER AND THEN A 12 FR. X 45 CM REINFORCED SHEATH WHICH WAS ADVANCED TO ABOVE THE RIGHT ATRIUM AND INTO THE SVC. THE SURFACER 10FR WORKSTATION WAS INSERTED INSIDE THE 12FR SHEATH FOLLOWED BY THE SURFACER DEVICE. USING ROTATIONAL ANGIOGRAPHY, THE SURGEON NOTED THAT THE SURFACER DEVICE ADVANCEMENT COULD POTENTIALLY PIERCE THE RIGHT SUBCLAVIAN ARTERY. THE WORKSTATION AND THE SURFACER SYSTEM WERE REPOSITIONED, AND ROTATIONAL ANGIOGRAPHY PREDICTED A SAFER COURSE THAT WOULD NOT INJURE THE SUBCLAVIAN ARTERY. THE SURFACER WAS THEN ADVANCED THROUGH THE OCCLUSION TO THE HEAD OF THE CLAVIC

  Patient problems: Extravasation; Hemothorax; Low Blood Pressure/ Hypotension; Unspecified Tissue Injury

  MAUDE report 16876901 ↗
• InjuryMar 17, 2023Positioning Problem

  PER THE INTENDED USE OF THE DEVICE, RIGHT FEMORAL VEIN ACCESS WAS OBTAINED, THE SURFACER 10FR WORKSTATION WAS ADVANCED OVER THE GUIDEWIRE WIRE AND POSITIONED WITHIN THE STUMP OF THE OCCLUSION. USING FLUOROSCOPY FOR VISUALIZATION, THE SURFACER DEVICE WAS INTRODUCED INTO THE 10F WORKSTATION. THE SURFACER DEVICE WAS THEN ADVANCED THROUGH THE OCCLUSION UNTIL THE DEVICE TIP AND WINDOW WERE ABOVE THE CLAVICLE. THE C-ARM WAS ADJUSTED TO LOCALIZE THE TIP OF THE DEVICE WITHIN THE CENTER OF THE EXTERNALLY PLACED TARGET. THE DEVICE WAS ADJUSTED, THE NEEDLE GUIDE WAS DEPLOYED AND NEEDLE WIRE ADVANCED. A 7F SHEATH WAS ADVANCED OVER THE WIRE AND SECURED USING A HEMOSTAT. THE CATHETER WAS THEN PULLED INTO THE BODY WITH THE TIP POSITIONED IN THE RIGHT ATRIUM BY RETRACTING THE SURFACER DEVICE. A POST-PROCEDURE ULTRASOUND OF THE NECK IDENTIFIED A HEMATOMA AND CATHETER POSITION WAS DEEMED SUBOPTIMAL. AFTER MANIPULATING CATHETER, THE HEMATOMA APPEARED TO BE ENLARGED. THE CATHETER WAS REMOVED AND THE ARTERIAL DEFECT REPAIRED BY BALLOON TAMPONADE. BALLOON WAS INFLATED TO NOMINAL PRESSURE AND MAINTAINED FOR 10 MINUTES. UPON BALLOON DEFLATION, ARTERIOGRAM SHOWED NO CONTRAST EXTRAVASATION AT THE SITE OF DE

  Patient problems: Hematoma

  MAUDE report 16573078 ↗
• InjuryJan 26, 2021Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method

  PATIENT EXPERIENCED POST-PROCEDURE BLEEDING REQUIRING INTERVENTION (STERNOTOMY) FOLLOWING A PROCEDURE INVOLVING USE OF A DEMERS CATHETER AND THE SURFACER SYSTEM. PHYSICIAN FROM HOSPITAL IN (B)(6) REPORTED BLEEDING FOLLOWING THE SURFACER SYSTEM PROCEDURE IN WHOM A PATIENT RECEIVED VASCULAR ACCESS VIA A DEMERS CATHETER. THE PHYSICIAN REPORTED THAT THE SURFACER SYSTEM PROCEDURE WAS CONDUCTED SUCCESSFULLY FOLLOWING THE IFU AND NO DEVICE MALFUNCTION WAS NOTED. AFTER THE PROCEDURE WAS COMPLETED, THERE WAS AN ACUTE DROP IN BLOOD PRESSURE AND BLOOD LOSS. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WITH CONTRAST IN BOTH LEGS WAS UTILIZED AND CONTRAST WAS VISUALIZED EXTRALUMINAL IN THE RIGHT THORAX, SUSPECTING ATRIAL INJURY. THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE THORACIC SURGERY DEPARTMENT OF THE UNIVERSITY HOSPITAL OF KIEL WHERE A STERNOTOMY WAS PERFORMED TO ADDRESS POST-SURGICAL BLEEDING. THE BLEEDING CEASED AND THE PATIENT WAS IN STABLE CONDITION, AND HAS RECOVERED. THE PHYSICIAN EXPLAINED THAT THE INSERTED DEMERS CATHETER WAS TOO SHORT AND PROBABLY SLIPPED OUT OF THE ATRIUM. AN EXPERIENCED PHYSICIAN PROCTOR WAS CONSULTED REGARDING THE CASE AND ASKED WHETHER USE OF THE SURFACER SYST

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 11236271 ↗