Zilver 635 G36229Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002362298), received between Dec 12, 2017 and Oct 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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.

• MalfunctionOct 15, 2024Off-Label Use; Off-Label Use

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449099 ↗
• MalfunctionJun 1, 2018Fracture; Delivery System Failure; Fracture; Delivery System Failure

  MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION" AND "STENT FRACTURE" AS REPORTED TO CUSTOMER RELATIONS: "WHILE UNSHEATHING CATHETER FOR STENT DEPLOYMENT, OUTER CATHETER SNAPPED, WHILE INNER PORTION OF CATHETER REMAINED INTACT. (CATHETER & UNSHEATHING MECHANISM BOTH FLUSHED WITH SALINE PRIOR TO USE). STENT KINKED & THEN FELL APART. NEEDED TO USE A NEW STENT, WHICH WAS DEPLOYED SUCCESSFULLY." ADDITIONAL INFORMATION PROVIDED ON 08MAY2018: "THE MIDPART OF THE FLEXOR SHEATH KINKED, THE PHYSICIAN COULD NOT DEPLOY THE STENT INSIDE THE PATIENT, THE FLEXOR SHEATH UNRAVELED AT THE PART OF THE KINK (YOU WILL SEE THIS WHEN THE DEVICE IS RETURNED)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7559585 ↗
• MalfunctionDec 12, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT THE DEVICE HAS BEEN RECEIVED AND A LAB EVALUATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITHIN 30 DAYS WITH THE FINAL INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: THE STENT WOULD NOT DEPLOY. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108352 ↗