Formula G56959Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002569598), received between Mar 9, 2018 and Mar 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P100028); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2018Device Handling Problem; Device Handling Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE STENT WAS ACCIDENTALLY REMOVED FROM THE DELIVERY CATHETER DURING PREP. THE TECH DID NOT REALIZE THAT THE STENT HAD NOT REMAINED ON THE DELIVERY CATHETER UNTIL THEY ATTEMPTED TO PLACE IT IN THE RENAL ARTERY. THE STENT WAS THEN FOUND ON THE PREP TABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7326364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100028. One submission often covers many models, so check the product and lot details in each record.

• Z-1940-2020 · Apr 15, 2020 · Terminated
  Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuratio