Visi-Pro™ PXB35-06-57-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169787735), received between Feb 17, 2026 and Aug 7, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗
• 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 ↗