Visi-Pro™ PXB35-05-37-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169787629), received between Jan 13, 2021 and Jul 9, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJul 9, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE STENT PXB35-05-27-135 VISI PRO 035 AND STENT PXB35-05-37-135 VISI PRO 035, THE FIRST STENT DETACHED FROM THE BALLOON AT THE TARGET LESION AND WAS SUBSEQUENTLY PULLED BACK AND DEPLOYED IN THE BRACHIAL ARTERY, WHICH WAS NOT THE INTENDED TARGET SITE. A SECOND STENT WAS THEN USED, BUT IT ALSO DETACHED FROM THE BALLOON IN THE AORTA JUST OUTSIDE OF THE SHEATH, WAS CAPTURED, PULLED BACK, AND DEPLOYED IN THE BRACHIAL ARTERY, AGAIN NOT AT THE INTENDED TARGET SITE. THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS THEN ABORTED. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE FIRST DEVICE, BUT NO EXCESSIVE FORCE WAS USED. BOTH STENTS REMAINED IMPLANTED IN THE BRACHIAL ARTERY. THE TARGET VESSEL WAS THE RENAL ARTERY/BRACHIAL ARTERY WITH A DIAMETER OF 5MM AND A COOK 6F SHEATH WAS USED. NO EMBOLIC PROTECTION, PRE-DILATION, OR POST-DILATION WAS PERFORMED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT WAS 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 22459580 ↗
• InjuryJan 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S RIGHT EXTERNAL ILIAC ARTERY. MODERATE VESSEL TORTUOSITY AND CALCIUM IS REPORTED. LESION EXHIBITED 95% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 5X60 BALLOON. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY. THE STENT IS REPORTED TO HAVE DISLODGED DURING DELIVERY TO THE LESION. THE WIRE POSITION WAS MAINTAINED AND A 3MM NANOCROSS WAS USED TO THREAD THROUGH THE STENT AND INFLATE IT. THEN THE BALLOON WAS UPSIZED TO TACK AGAINST VESSEL WALL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11160509 ↗