Formula G56968Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002569680), received between Jun 16, 2017 and Mar 4, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

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

• MalfunctionMar 4, 2019Difficult to Advance; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8385874 ↗
• MalfunctionMar 15, 2018Difficult to Advance; Difficult to Advance

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THEY WERE ABLE TO TRACK A COOK .014 ROADRUNNER AND WERE ABLE TO PASS TWO 14 LP COOK BALLOONS TO PREDILATE THE VESSEL. WHEN THEY WENT IN WITH THE BALLOON EXPANDABLE STENT, IT WOULD NOT PASS. THIS WAS THE CASE FIRST FOR THE 5 X 20 (B)(4) AND THEN FOR THE 5 X 16 (B)(4). NEITHER WOULD PASS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH A BOSTON SCIENTIFIC BALLOON EXPANDABLE STENT. 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: Calcium Deposits/Calcification; Stenosis

  MAUDE report 7340666 ↗
• MalfunctionJun 16, 2017Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN THE STENT WAS PLACED IN THE PATIENT, IT LOOKED AS THOUGH THE STENT HAD SLIPPED OFF THE BALLOON. THIS CAUSED THE PHYSICIAN TO WORRY THAT THE STENT WOULD BE MALPOSITIONED. THE PRODUCT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S PRODUCT. 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 Known Impact Or Consequence To Patient

  MAUDE report 6645935 ↗

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