Visi-ProRecalls & reported problems across all models
Covidien LP · 66 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 178
- Deaths reported
- 3
- Injuries reported
- 92
- Recalls
- 0
We found 66 models of Visi-Pro by Covidien LP in the FDA's device registry (GUDID). Together they are named in 178 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2017 and Aug 7, 2026 — classified as 3 deaths, 92 injuries, 83 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (105 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
Reports received per month, all models
Most reported Visi-Pro problems
Device problems
- Device Dislodged or Dislocated105
- Material Deformation22
- Detachment of Device or Device Component19
- Malposition of Device19
- Activation, Positioning or Separation Problem17
- Difficult to Remove16
- Burst Container or Vessel13
- Positioning Problem13
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- No Consequences Or Impact To Patient54
- Patient Problem/Medical Problem18
- Insufficient Information11
- Unspecified Tissue Injury10
- Device Embedded In Tissue or Plaque5
- Injury4
- No Known Impact Or Consequence To Patient3
Visi-Pro models
66 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Visi-Pro™ PXB35-05-17-080STENT, ILIAC10 reports
- Visi-Pro™ PXB35-07-37-080Stents, drains and dilators for the biliary ducts9 reports
- Visi-Pro™ PXB35-06-17-080STENT, ILIAC1 death7 reports
- Visi-Pro™ PXB35-08-27-135STENT, ILIAC7 reports
- Visi-Pro™ PXB35-07-17-080Stents, drains and dilators for the biliary ducts6 reports
- Visi-Pro™ PXB35-07-27-080STENT, ILIAC5 reports
- Visi-Pro™ PXB35-07-37-135Stents, drains and dilators for the biliary ducts5 reports
- Visi-Pro™ PXB35-08-37-080Stents, drains and dilators for the biliary ducts5 reports
- Visi-Pro™ PXB35-05-17-135STENT, ILIAC4 reports
- Visi-Pro™ PXB35-06-27-135Stents, drains and dilators for the biliary ducts4 reports
- Visi-Pro™ PXB35-07-17-135STENT, ILIAC4 reports
- Visi-Pro PXB35-07-27-135Stents, drains and dilators for the biliary ducts4 reports
- Visi-Pro™ PXB35-07-57-080Stents, drains and dilators for the biliary ducts4 reports
- Visi-Pro™ PXB35-07-57-135STENT, ILIAC4 reports
- Visi-Pro™ PXB35-08-17-135Stents, drains and dilators for the biliary ducts4 reports
- Visi-Pro™ PXB35-08-27-080STENT, ILIAC4 reports
- Visi-Pro™ PXB35-08-37-135STENT, ILIAC4 reports
- Visi-Pro™ PXB35-08-57-080STENT, ILIAC4 reports
- Visi-Pro PXB35-07-37-080CATHETER, BILIARY, DIAGNOSTIC4 reports
- Visi-Pro PXB35-08-27-135CATHETER, BILIARY, DIAGNOSTIC4 reports
- Visi-Pro PXB35-08-37-135CATHETER, BILIARY, DIAGNOSTIC4 reports
- Visi-Pro™ PXB35-06-12-080Stents, drains and dilators for the biliary ducts3 reports
- Visi-Pro™ PXB35-08-17-080STENT, ILIAC3 reports
- Visi-Pro™ PXB35-08-57-135STENT, ILIAC3 reports
- Visi-Pro™ PXB35-09-27-080Stents, drains and dilators for the biliary ducts3 reports
- Visi-Pro PXB35-07-17-080CATHETER, BILIARY, DIAGNOSTIC3 reports
- Visi-Pro PXB35-07-17-135CATHETER, BILIARY, DIAGNOSTIC3 reports
- Visi-Pro™ PXB35-05-27-135STENT, ILIAC2 reports
- Visi-Pro™ PXB35-05-37-135Stents, drains and dilators for the biliary ducts2 reports
- Visi-Pro™ PXB35-06-17-135Stents, drains and dilators for the biliary ducts2 reports
- Visi-Pro™ PXB35-06-57-135Stents, drains and dilators for the biliary ducts2 reports
- Visi-Pro™ PXB35-09-27-135Stents, drains and dilators for the biliary ducts2 reports
- Visi-Pro PXB35-06-17-135CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-06-27-080CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-06-57-080CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-07-37-135CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-08-17-080CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-08-17-135CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-08-27-080CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-08-37-080CATHETER, BILIARY, DIAGNOSTIC1 death2 reports
- Visi-Pro PXB35-08-57-135CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro PXB35-09-57-135CATHETER, BILIARY, DIAGNOSTIC2 reports
- Visi-Pro™ PXB35-05-12-080STENT, ILIAC1 report
- Visi-Pro™ PXB35-05-37-080Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-06-27-080Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-06-37-080Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-06-57-080Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-09-17-135Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-09-37-135Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-09-57-080STENT, ILIAC1 report
- Visi-Pro™ PXB35-10-27-080Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-10-27-135Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro™ PXB35-10-57-135Stents, drains and dilators for the biliary ducts1 report
- Visi-Pro PXB35-05-17-080CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-05-27-080CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-05-27-135CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-06-27-135CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-07-27-080CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-07-27-135CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-07-57-080CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-07-57-135CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-09-37-080CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-09-37-135CATHETER, BILIARY, DIAGNOSTIC1 death1 report
- Visi-Pro PXB35-09-57-080CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-10-27-135CATHETER, BILIARY, DIAGNOSTIC1 report
- Visi-Pro PXB35-10-37-080CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Visi-Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Malposition of Device; Detachment of Device or Device Component
It was reported that during peripheral arterial intervention involving the left superficial femoral (SFA), common femoral (CF), and anterior tibial (AT) arteries, there was moderate calcification. Lesion stenosis of the SF was 99%, CF was 90% and AT was 75%. The lesion length in the SFA was 150mm, lesion length in CF was 40mm and the lesion length in the AT was 80mm. The SFA has an artery diameter of 6mm, CF was 6mm and the AT was 3mm in diameter. The vessel was pre-dilated with a Chocolate balloon. A Visi-Pro stent was advanced through a 6/7 non Medtronic sheath with moderate resistance. The entire stent detached from the delivery system and was radiographically visualized in the distal left anterior tibial artery outside the sheath. The detached stent was expanded with an EverCross balloon at 4 atmospheres, and an Onyx device was used to secure stent placement. Femoral access was obtained, and treatment of the common femoral and superficial femoral lesions was completed with Everflex Entrust and IN.PACT Admiral without issue . The delivery system was removed, and the procedure was completed using a new device. No patient complications have been reported as a result of this event.
Patient problems: Embolism/Embolus
MAUDE report 50171356 ↗MalfunctionMar 24, 2026Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE RENAL ARTERY USING THE VISI PRO STENT, THE PRONGS AT THE BACK OF THE STENT WERE OBSERVED "SPRINGING" OR "STICKING OUT" ONCE ADVANCED THROUGH THE SHEATH. THIS ISSUE WAS NOT PRESENT DURING DEVICE PREPARATION OR WHEN ADVANCING THE STENT INTO THE SHEATH OVER THE GUIDEWIRE, BUT WAS NOTICED AFTER THE STENT LEFT THE SHEATH INSIDE THE BODY AND TRAVELED INTO THE AORTA. THE PRONGS WERE DESCRIBED AS "BARELY" STICKING OUT, AND THE PHYSICIAN ELECTED TO PROCEED WITH DEPLOYMENT. THE STENT WAS DEPLOYED IN THE RENAL ARTERY, APPEARED WELL APPOSED, AND THE BALLOON CATHETER SYSTEM WAS REMOVED SAFELY. A 6FR NON MEDTRONIC SHEATH AND A 0.035" GUIDEWIRE WERE USED. FINAL PICTURES WERE TAKEN DURING THE PROCEDURE, AND NO ISSUES WERE OBSERVED DURING USE OR DEPLOYMENT. THE VESSEL WAS POST-DILATED USING THE BALLOON ON THE VISI PRO CATHETER. NO EMBOLIC PROTECTION WAS USED, AND THE VESSEL WAS NOT PRE-DILATED. THE PROCEDURE WAS COMPLETED WITHOUT INJURY OR INTERVENTION, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674265 ↗MalfunctionMar 18, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING PRE-RENAL STENTING FOR LASER FENESTRATED ENDOVASCULAR AORTIC REPAIR IN A PATIENT, MULTIPLE ISSUES OCCURRED INVOLVING THE STENT VISI PRO 035. THE PROCEDURE TARGETED THE PROXIMAL RIGHT AND LEFT RENAL ARTERIES, WHICH EXHIBITED MINIMAL TORTUOSITY AND CALCIFICATION, WITH A VESSEL DIAMETER OF 4.8MM AND NO LESION STENOSIS. THE FIRST STENT DISLODGED DURING PREPARATION PRIOR TO INSERTION INTO THE PATIENT. A SECOND STENT DISLODGED DURING USE IN THE PATIENT BUT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. A THIRD STENT ALSO DISLODGED DURING USE IN THE PATIENT, AND A SNARE ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT. IN EACH INSTANCE, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629461 ↗InjuryMar 18, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING PRE-RENAL STENTING FOR LASER FENESTRATED ENDOVASCULAR AORTIC REPAIR IN A PATIENT, MULTIPLE ISSUES OCCURRED INVOLVING THE STENT VISI PRO 035. THE PROCEDURE TARGETED THE PROXIMAL RIGHT AND LEFT RENAL ARTERIES, WHICH EXHIBITED MINIMAL TORTUOSITY AND CALCIFICATION, WITH A VESSEL DIAMETER OF 4.8MM AND NO LESION STENOSIS. THE FIRST STENT DISLODGED DURING PREPARATION PRIOR TO INSERTION INTO THE PATIENT. A SECOND STENT DISLODGED DURING USE IN THE PATIENT BUT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. A THIRD STENT ALSO DISLODGED DURING USE IN THE PATIENT, AND A SNARE ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT. IN EACH INSTANCE, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 24626289 ↗MalfunctionFeb 17, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ATTEMPTED ADVANCEMENT OF THE STENT PXB35-06-57-135 VISI PRO 035 TO A SEVERELY CALCIFIED, 70% STENOSED PROXIMAL COMMON ILIAC ARTERY LESION, THE DEVICE TIP DETACHED. THE DEVICE/COMPONENT EMBOLIZATION MOST LIKELY OCCURRED AT THE DISTAL EXTERNAL ILIAC DURING THE ATTEMPTED PASSAGE. THE LESION WAS PRE-DILATED WITH A 5MM ADMIRAL XTREME PTA BALLOON. THE DETACHED PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT, AS THE CATHETER WAS INTACT UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING A SELF-EXPANDING STENT INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Embolism/Embolus
MAUDE report 24363036 ↗MalfunctionFeb 16, 2026Use of Device Problem
IT WAS REPORTED THAT AN EXPIRED VISI PRO 035 WAS IMPLANTED, WITH THE EXPIRATION DATE BEING JANUARY 8, 2026, AND THE EXPIRATION DATE WAS NOT CHECKED PRIOR TO IMPLANTATION. THE STENT WAS PLACED IN A VESSEL WITH A DIAMETER OF 7MM. NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR INJURIES WERE REPORTED. THE STENT REMAINED IN USE AND WAS NOT REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343567 ↗MalfunctionJan 26, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE VISI PRO 035, THERE WAS A DELAY IN SURGERY OF 10 MINUTES DUE TO PARTIAL DEPLOYMENT OF THE DEVICE AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT AND REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE STENT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178327 ↗MalfunctionJan 13, 2026Detachment of Device or Device Component
LIMITED INFORMATION REPORTED THAT DURING THE IMPLANT OF 2 VISIPRO STENTS ABOUT 8 YEARS AGO, A "PIECE OF THE BLADE BROKE OFF" AND HAS NOW MIGRATED THROUGH THE PATIENTS BODY. IT IS NOW BEHIND THEIR LEFT KNEE, BUT THE ORIGINAL POSITION WAS UNKNOWN AND THEY WERE ORIGINALLY TOLD THAT THE FOREIGN OBJECT WOULD NOT MIGRATE PAST THE STENT BUT IT NOW HAS. THE PATIENT DOES NOT REPORT ANY ISSUES ASSOCIATED WITH THIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053294 ↗MalfunctionJan 13, 2026Detachment of Device or Device Component
LIMITED INFORMATION REPORTED THAT DURING THE IMPLANT OF 2 VISIPRO STENTS ABOUT 8 YEARS AGO, A "PIECE OF THE BLADE BROKE OFF" AND HAS NOW MIGRATED THROUGH THE PATIENTS BODY. IT IS NOW BEHIND THEIR LEFT KNEE, BUT THE ORIGINAL POSITION WAS UNKNOWN AND THEY WERE ORIGINALLY TOLD THAT THE FOREIGN OBJECT WOULD NOT MIGRATE PAST THE STENT BUT IT NOW HAS. THE PATIENT DOES NOT REPORT ANY ISSUES ASSOCIATED WITH THIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053250 ↗MalfunctionJan 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE TO EXTEND THE LOWER LIMB OF A GRAFT IN A PATIENT, A STENT WAS INTRODUCED INTO THE SHEATH AND ADVANCED INTO THE LEFT DISTAL COMMON ILIAC ARTERY, WHICH WAS NOTED TO BE HEAVILY CALCIFIED. SEVERE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT DUE TO THE CALCIFIED VESSEL. UPON ATTEMPTING TO REMOVE THE STENT SYSTEM, THE STENT WAS FOUND TO HAVE DETACHED FROM THE BALLOON AND REMAINED IN THE SHEATH, RESULTING IN STENT DISLODGEMENT AND THE STENT NOT BEING DEPLOYED IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018430 ↗MalfunctionSep 2, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING DELIVERY OF THE STENT VISI PRO 035 TO THE LESION IN THE RIGHT MID COMMON ILIAC ARTERY, WHICH HAD 80% STENOSIS AND SEVERE CALCIFICATION, STENT DISLODGEMENT OCCURRED. THE STENT DISLODGMENT OCCURED IN THE BRACHIAL ARTERY AT THE ACCESS SITE AND WAS REMOVED BY PULLING IT OUT WITH THE SHEATH. THE LESION WAS NOT PRE-DILATED, NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING FEMORAL ACCESS, AND TWO VISI PRO STENTS WERE SUCCESSFULLY DEPLOYED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931923 ↗InjuryAug 26, 2025Fracture; Fracture
MEDTRONIC PATIENT SERVICES RECEIVED A CALL ABOUT AN ISSUE WITH A VISIPRO STENT. IT WAS REPORTED THAT POST-OP, THE STENT IMPLANTED IN THE LEFT PULMONARY ARTERY (LPA) EXPERIENCED A FRACTURE. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP PROCEDURE TO IMPLANT ANOTHER STENT IN ORDER TO REPAIR THE FRACTURED STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892793 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE A VISI PRO STENT AND A PROTÉGÉ EVERFLEX STENT WERE USED TO TREAT THE LEFT COMMON ILIAC, EXTERNAL ILIAC. APPROXIMATELY 11 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS WITHIN THE DISTAL EXTERNAL ILIAC/COMMON FEMORAL VESSELS. FROM LAST FOLLOW UP, PATIENT COMPLAINED OF BILATERAL HIP PAIN AND ANKLE BRACHIAL INDEX DROPPED BILATERALLY. WENT TO OPERATION ROOM FOR LEFT FEMORAL POPLITEAL BYPASS, BALLOON ANGIOPLASTY OF LEFT EXTERNAL ILIAC ARTERY (TARGET LESION) STENTS DUE TO RESTENOSIS. PATIENT RECOVERED.
Patient problems: Pain; Stenosis
MAUDE report 22804632 ↗InjuryJul 31, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE VISI PRO 035, THE BALLOON BURST. THE RUPTURED BALLOON HAD TO BE SNARED OUT, AND BALLOON DETACHMENT OCCURRED DURING THE EVENT. ALL BALLOON FRAGMENTS WERE RETRIEVED FROM THE VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675638 ↗MalfunctionJul 16, 2025Difficult to Insert; Compatibility Problem; Material Deformation; Difficult to Insert; Compatibility Problem; Material Deformation
IT WAS REPORTED THAT THE STENT PXB35-07-57-080 VISI PRO 035 WAS INTENDED TO BE USED TO TREAT PLAQUE IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. DURING THE PROCEDURE, THERE WERE DIFFICULTIES INSERTING THE DEVICE, AND MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING IT. IT WAS STUCK, DIFFICULT TO PUSH FORWARD OR PULL BACK ON THE WIRE, SO THE PHYSICIAN COULD NOT GET IT OUT OF THE PATIENT. THE PHYSICIAN HAD TO PULL THE ENTIRE VISIPRO OUT WITH THE TERUMO SHEATH WITH NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE. THE VESSEL WAS PRE-DILATED WITH A NON-MEDTRONIC 7X60X80 DILATION DEVICE, THE ARTERY DIAMETER WAS MEASURED AT 7MM, AND THE DEGREE OF TORTUOSITY WAS ASSESSED AS MODERATE. A 45CM 6FR NON-MEDTRONIC SHEATH AND A 180CM NON-MEDTRONIC GUIDEWIRE WERE USED. THE PROCEDURE WAS COMPLETED USING A NEW EVERFLEX 8X80X120 DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE STENT WAS DAMAGED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22517234 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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