WALLSTENT™ RP Endoprosthesis M001712100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729345671), received between Dec 4, 2019 and Jul 15, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 15, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE STENT DID NOT FULL EXPAND, REQUIRING ADDITIONAL INTERVENTION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED UPPER LEFT ARM AND DIRECTLY ABOVE V SIDE ANASTOMOSIS. A 6.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS USED TOGETHER WITH TWO WALLSTENT (8X47X75 AND 7X34X75). THE WALLSTENTS WERE IMPLANTED ON (B)(6) 2020. DURING THE PROCEDURE, THE FIRST WALLSTENT THAT WAS PLACED IN THE MIDDLE PART OF THE UPPER ARM DURING THE PREVIOUS TREATMENT, WAS EXPANDED TO 6 ATM FOR FOUR TIMES WITH A SLIGHT SHIFT FROM THE CENTRAL PART TO THE PERIPHERY EACH TIME. INDENTATION WAS NOT OBTAINED AS CONFIRMED BY CONTRAST IMAGING, THUS ADDITIONAL EXPANSION WAS PERFORMED AT 10 ATM FOR THREE TIMES, SIMILARLY WHILE SHIFTING. AFTER THAT, WITHOUT REMOVING FROM THE SHEATH, THE SECOND WALLSTENT THAT WAS PREVIOUSLY PLACED WAS ON THE ELBOW AND V SIDE ANASTOMOSIS, AND WAS EXPANDED AT 6 LOCATIONS AT 10 ATM IN THE SAME WAY. ALSO, THE CENTRAL SIDE AND THE PERIPHERAL SIDE WITHIN THE STENT ARE EXPANDED ONCE AT 10 ATM. WHEN IMAGING WAS TAKEN OF THE WHOLE ARM FOR THE PURPOSE OF FINAL CONFIRMATION, INCOMPLETE DILATION/EXPANSION WAS OBSERVED IN BOTH THE MIDDLE PART OF THE UPPER A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277704 ↗
• MalfunctionDec 4, 2019Activation Failure; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-NOV-2019. IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A VENTRICULO-ATRIAL SHUNT. A 7X34X75/ ILIAC 6F UNISTEP PLUS REDUCED PROFILE WALLSTENT WAS ADVANCED BUT FAILED TO DEPLOY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE AND DEVICE FRACTURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412545 ↗