Zilver 635 G23812Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002238128), received between Oct 20, 2020 and Mar 16, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2022Break; Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Break; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "WENT TO DEPLOY THE STENT, IT WOULD NOT DEPLOY. A NEW G23812-ZILBS-635-6-12 WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY." DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? - NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. 3.2.13 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A. 3.2.14 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION, INSERTION, DURING STENT PLACEMENT, REMOVING THE INTRODUCER POST STENT PLACEMENT? - DURING STENT PLACEMENT. 3.2.15 WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? - YES. 3.2.16 WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? - NO. 3.2.17 WHAT WAS THE LENGTH AND DIAMETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13788590 ↗
• MalfunctionApr 13, 2021Break; Dent in Material; Break; Dent in Material

  PER REP - (B)(6) 2021 - THE DEVICE DID NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE. NO ADVERSE EFFECTS TO THE PATIENT REPORTED CURRENTLY.

  Patient problems: Insufficient Information

  MAUDE report 11654439 ↗
• MalfunctionNov 3, 2020Break; Material Separation; Break; Material Separation

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A CORRECTION MADE TO THE FILE. THE RISK ASSESSMENT HAS BEEN UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10776735 ↗
• MalfunctionOct 20, 2020Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  THE INVESTIGATION WAS CONCLUDED ON THE 19-MAR-2021, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10706539 ↗