Visi-Pro™ PXB35-07-37-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169787797), received between Sep 23, 2019 and Oct 18, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE TWO VISIPRO BALLOON EXPANDABLE STENTS WITH A 45CM 6FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH DURING TREATMENT OF A 25MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID COMMON ILIAC ARTERY. SEVERE VESSEL CALCIFICATION AND MODERATE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 70-80% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT(S) WERE PARTIALLY RETRIEVED USING A 10 AND 15MM SNARE. NEXT, BALLOON ANGIOPLASTY WAS PERFORMED OF THE LEFT COMMON ILIAC ARTERY USING 3.0X25 AND 5.0X20 MM BALLOONS TO CRUSH THE STENTS TO THE LEFT COMMON ILIAC WALL. BOTH STENTS WERE DISLODGED, DETACHED AND CRUSHED INTO THE LEFT COMMON ILIAC WALL. THE PATIENT WILL BE BROUGHT BACK AT A FUTURE DAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955156 ↗
• MalfunctionOct 17, 2022Material Deformation; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO USE A VISIPRO STENT FOR TREATMENT OF A 30 MM CALCIFIED AND FIBROUS LESION WITH 80% STENOSIS IN THE MID LEFT ILIAC ARTERY. THE ARTERY HAD A DIAMETER OF 7MM WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED  THE STENT WOULDN¿T TRACK OVER THE WIRE TO THE INTENDED STENT PLACEMENT SITE, THE PHYSICIAN REMOVED THE STENT AND BALLOON UNDEPLOYED.  THE PHYSICIAN THEN PRE DILATED WITH A 6 MM BALLOON. WHEN TRYING TO RE INSERT THE STENT, IT LOOKED KINKED UP ON THE SIDE AND REQUESTED A NEW STENT THAT WASN¿T DAMAGED.  THE SECOND STENT TRACKED AND WAS PLACED WITHOUT DIFFICULTY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613610 ↗
• InjurySep 13, 2021Malposition of Device; Activation, Positioning or Separation Problem; Difficult to Advance; Device Dislodged or Dislocated; Malposition of Device; Activation, Positioning or Separation Problem; Difficult to Advance; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE VISIPRO BALLOON EXPANDABLE STENT ALONG WITH 6FR 45CM SHEATH AND GUIDEWIRE DURING PROCEDURE TO TREAT THE LEFT COMMON ILIAC ARTERY. THERE WAS NO EMBOLIC PROTECTION USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING REMOVAL FOLLOWING FAILED DELIVERY, STENT DISLODGEMENT OCCURRED. PHYSICIAN WAS TRYING TO FIX LEFT ILIAC, THROUGH A RIGHT GROIN ACCESS. BALLOON AND STENT WOULD NOT TRACK AND GO UP AND OVER. PHYSICIAN TRIED TO PULL BALLOON/STENT BACK OUT OF THE SHEATH AND SAW THAT STENT CAME OFF BALLOON. THEY COULD NOT RETRIEVE THE STENT OS EVENTUALLY DEPLOYED THE STENT IN THE RIGHT ILIAC. THE DISLODGED STENT WAS ATTEMPTED TO BE REMOVED BUT UNSUCCESSFUL AND EVENTUALLY STENT WAS DEPLOYED IN THE RIGHT ILIAC, IN AN UNINTENDED LESION SITE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THERE WAS NO SNARE USED IN THE ATTEMPT TO REMOVE THE DISLODGED STENT. THERE WAS NO VESSEL DAMAGE DUE TO THE EVENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458923 ↗
• InjuryJan 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL PACLITAXEL ELUTING STENT AND VISIPRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH WERE 7MM AND 57MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED WITH A 6MM X 100MM DEVICE. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED (DISMOUNTED) FROM THE BALLOON AND THE DISTAL EDGE OF THE STENT DETACHED AND REMAINED NEXT TO THE ARTERIAL WALL. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SMALL PIECE OF STENT THAT WAS DETACHED. THE PHYSICIAN ATTEMPTED TWO VISIPRO STENTS (7 X 37) AND THEY DISLODGED DURING ADVANCEMENT TO THE TARGET VESSEL. PHYSICIAN WAS ADVANCING THE STENTS THROUGH THE RIGHT COMMON FEMORAL ACCESS, THROUGH PREVIOUSLY PLACED STENTS IN THE RIGHT ILIAC SYSTEM, ACROSS THE BIFURCATION OF THE LEFT ILIAC. THE LEFT ILIAC WAS THE TARGET LESION. THE TWO VISIPRO DISLODGED STENTS WERE IMPLANTED IN AN

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11251749 ↗
• InjuryJan 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL PACLITAXEL ELUTING STENT AND VISIPRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH WERE 7MM AND 57MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED WITH A 6MM X 100MM DEVICE. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED (DISMOUNTED) FROM THE BALLOON AND THE DISTAL EDGE OF THE STENT DETACHED AND REMAINED NEXT TO THE ARTERIAL WALL. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SMALL PIECE OF STENT THAT WAS DETACHED. THE PHYSICIAN ATTEMPTED TWO VISIPRO STENTS (7 X 37) AND THEY DISLODGED DURING ADVANCEMENT TO THE TARGET VESSEL. PHYSICIAN WAS ADVANCING THE STENTS THROUGH THE RIGHT COMMON FEMORAL ACCESS, THROUGH PREVIOUSLY PLACED STENTS IN THE RIGHT ILIAC SYSTEM, ACROSS THE BIFURCATION OF THE LEFT ILIAC. THE LEFT ILIAC WAS THE TARGET LESION. THE TWO VISIPRO DISLODGED STENTS WERE IMPLANTED IN AN

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11251721 ↗
• InjurySep 8, 2020Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A 7MM VISIPRO BALLOON-EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 50MM CALCIFIED LESION IN THE PATIENT¿S DISTAL RIGHT COMMON ILIAC ARTERY. VESSEL DIAMETER REPORTED AS 7MM. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A NON-MEDTRONIC BALLOON. EMBOLIC PROTECTION WAS NOT USED. IT IS REPORTED DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. CONTRALATERAL ACCESS WAS USED FOR TREATMENT OF THE RIGHT COMMON ILIAC. INITIALLY AN 8MM VISIPRO WAS SUCCESSFULLY PLACED THROUGH THE 6FR SHEATH. THE PHYSICIAN WANTED TO PLACE A SECOND STENT DISTAL TO THE FIRST AS INTERVENTION. PRE-DILATION WAS PERFORMED, AND THE STENT WAS DELIVERED THROUGH THE FIRST STENT BUT DID NOT DEPLOY. THE PHYSICIAN THEN DECIDED TO PLACE A SELF-EXPANDING STENT, BUT WHEN AN ATTEMPT WAS MADE TO REMOVE THE UNDEPLOYED VISIPRO THE STENT WAS TRACKED THROUG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10500589 ↗
• MalfunctionJun 12, 2020Material Deformation; Material Deformation

  PATIENT CALLER REPORTED LEFT LEG STENT "COLLAPSING". THE PATIENT REPORTED HAVING TWO STENTS IMPLANTED, ONE IN THE RIGHT LEG AND ONE IN THE LEFT LEG . APPROXIMATELY 4.5 MONTHS POST-PROCEDURE, THE PATIENT¿S PHYSICIAN INFORMED HIM THAT THE STENT IMPLANTED IN THE LEFT LEG HAS COLLAPSED, AND TREATMENT OPTIONS WILL BE LOOKED AT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Obstruction/Occlusion; Reocclusion

  MAUDE report 10147686 ↗
• InjuryApr 22, 2020Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT SYSTEM DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENT¿S RIGHT SUPERIOR MESENTERIC ARTERY (SMA) OF DIAMETER 7MM. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN ATTEMPTED TO PULL THE DEVICE BACK AND THE STENT IS REPORTED TO HAVE DISLODGED FROM THE BALLOON UNKNOWINGLY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER WIRE AND CATHETER AND OBSERVED THE UNEXPANDED STENT WHICH HAD DISLODGED. THE PHYSICIAN THEN ATTEMPTED TO USE A SNARE KIT TO RETRIEVE THE UNEXPANDED STENT. THE STENT WAS CAPTURED BUT LOST IN THE ARTERIAL WALL. A CUT-DOWN WAS THEN PERFORMED TO RETRIEVE THE STENT. THE PHYSICIAN THEN REGAINED ACCESS SUCCESSFULLY AND PLACED A PARAMOUNT MINI STENT AT THE TARGET LESION TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985230 ↗
• MalfunctionSep 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A VISI PRO STENT WAS ATTEMPTED TO BE USED WITH A 6FR NON-MEDTRONIC SHEATH AND .035 WIRE DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT COMMON ILIAC ARTERY OF DIAMETER 7MM. SEVERE CALCIFICATION IS REPORTED. LESION EXHIBITED 99% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE THE PHYSICIAN TRIED TO PUSH THE VISI PRO THROUGH THE LESION RESULTING IN THE STENT BECOMING DISLODGED FROM THE BALLOON. THE BALLOON WAS ADVANCED BACK THROUGH THE STENT AND DEPLOYED IT IN THE EXTERNAL ILIAC ARTERY. ANOTHER STENT WAS THEN USED TO TREAT THE TARGET LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9103746 ↗