Zilver 635 G43861Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002438610), received between Jun 4, 2020 and Jun 12, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2020Off-Label Use; Off-Label Use

  CANCELLATION REPORT: FILE TO BE CANCELLED, OFF LABEL USE OF DEVICE TO BE CAPTURED UNDER PR 300907 (MANUFACTURER REPORT # 3001845648-2020-00350). THIS CANCELLATION REPORT IS BEING SUBMITTED DUE TO CLINICAL INPUT RECEIVED CONFIRMING THE OFF LABEL USE IS RELATED TO THE INITIAL COMPLAINT ISSUE WHICH IS CAPTURED UNDER # 3001845648-2020-00350. THIS COMPLAINT IS NO LONGER REQUIRED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10147542 ↗
• InjuryJun 12, 2020Fracture; Off-Label Use; Deformation Due to Compressive Stress; Material Deformation; Fracture; Off-Label Use; Deformation Due to Compressive Stress; Material Deformation

  A G52359-PTA5-35-80-8-4.0 WAS USED TO PRE DILATE DURING STENT PLACEMENT. THE G43861-ZIV6-35-80-9-40 WAS PLACED SUCCESSFULLY WITH NO ISSUES. DURING POST DILATING THE STENTED AREA, THE G52359-PTA5-35-80-8-4.0 RUPTURED. THE USER REMOVED THE SHEATH AND THE BALLOON AS A UNIT. DURING REMOVAL, THE BALLOON CAUGHT ON THE STENT, INVERTED IT AND BALLED IT UP. THE TIP OF THE BALLOON BECAME STUCK ON THE STENT AND DETACHED. THE DETACHED BALLOON TIP AND DAMAGED STENT WERE SEWN TO THE ARTERIAL WALL TO AWAIT REMOVAL SURGERY. THE STENT WILL BE REPLACED AS THE PATIENT IS A DIALYSIS PATIENT AND RELIES ON THIS STENT AS A LIFELINE. 301562 CREATED TO CAPTURE OFF LABEL USE OF ZIV6-35-80-9-40 IN THE UPPER ARM. IMAGING REVIEW ON 10-JUN-2020: "THE ZIV6-35-80-9-40 MEASURED ONLY 25MM LONG. ALTHOUGH SOME FORESHORTENING ON THE IMAGE LIKELY ACCENTUATES THIS, THE STENT¿S SUBJECTIVE APPEARANCE IS ALSO CONSISTENT WITH IMPLANTATION IN SIGNIFICANT LENGTHWISE COMPRESSION". THIS REPORT IS BEING SUBMITTED TO UPDATE THE EVENT DESCRIPTION WITH IMAGE REVIEW FINDINGS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10147509 ↗
• InjuryJun 4, 2020Material Separation; Material Separation

  A G52359-PTA5-35-80-8-4.0 WAS USED TO PRE DILATE DURING STENT PLACEMENT. THE G43861-ZIV6-35-80-9-40 WAS PLACED SUCCESSFULLY WITH NO ISSUES. DURING POST DILATING THE STENTED AREA, THE G52359-PTA5-35-80-8-4.0 RUPTURED. THE USER REMOVED THE SHEATH AND THE BALLOON AS A UNIT. DURING REMOVAL, THE BALLOON CAUGHT ON THE STENT, INVERTED IT AND BALLED IT UP. THE TIP OF THE BALLOON BECAME STUCK ON THE STENT AND DETACHED. THE DETACHED BALLOON TIP AND DAMAGED STENT WERE SEWN TO THE ARTERIAL WALL TO AWAIT REMOVAL SURGERY. THE STENT WILL BE REPLACED AS THE PATIENT IS A DIALYSIS PATIENT AND RELIES ON THIS STENT AS A LIFELINE. FURTHER INFORMATION PROVIDED STATES: PATIENT GOT INFECTED AND HAD TO HAVE AN EXPLANT OF THE BALLOON PART AND STENT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10120248 ↗