Flexor G11634Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002116344), received between May 18, 2017 and Feb 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 26FEB2025. CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED, AND THE BIFURCATION WAS NOT STEEP OR CALCIFIED. ANOTHER MANUFACTURER¿S WIRE GUIDE, ATHERECTOMY DEVICE, AND STENT WERE PLACED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE DILATOR WAS REINSERTED PRIOR TO REMOVAL OF THE SHEATH OVER THE WIRE GUIDE. THE SHEATH HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT, AT WHICH POINT THE SHEATH SEPARATED AT THE HUB. PER THE REPORTER, THE SHEATH (¿OUTER LAYER¿) THEN SLID FREELY OVER THE DILATOR (¿INNER LAYER¿). THE USER IDENTIFIED THE ISSUE IMMEDIATELY, ADJUSTED HIS GRIP AND HELD THE SHEATH AND DILATOR TOGETHER, AND CAREFULLY REMOVED THE DEVICE OVER THE WIRE. NO ADDITIONAL PROCEDURES WERE NEEDED, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462955 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AS REPORTED, DURING AN ANGIOPLASTY AND STENTING PROCEDURE, THE DISTAL HUB/VALVE OF A FLEXOR RAABE GUIDING SHEATH WAS SEPARATED FROM THE SHEATH. THE PROCEDURE WAS INVOLVING A RIGHT LOWER LIMB CRITICAL ISCHEMIA. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830377 ↗
• MalfunctionNov 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, PRIOR TO PATIENT CONTACT, THE DILATOR OF A FLEXOR RAABE GUIDING SHEATH WAS FOUND TO BE SPLIT UPON FLUSHING THE DEVICE. THE PACKAGE WAS NOT DAMAGED AND THE DEVICE WAS STORED "AS REQUIREMENT". THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10855980 ↗
• MalfunctionJul 18, 2019Unsealed Device Packaging; Unsealed Device Packaging

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8803359 ↗
• MalfunctionMay 18, 2017Defective Device; Material Integrity Problem

  DURING PREPARATION OF THE PROCEDURE IT WAS NOTED THAT THE INTRODUCER HAD A DEFECT IN THE DILATOR, THERE WAS THE PRESENCE OF CLEFT IN THE TIP. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6577112 ↗
• MalfunctionMay 18, 2017Material Separation; Material Separation

  IT WAS REPORTED DURING A RECANALIZATION OF ARTERIOSCLEROSIS OBLITERANS PROCEDURE USING A FLEXOR RAABE GUIDING SHEATH, THE SHEATH WAS SEPARATED FROM THE HEMOSTASIS VALVE. THE END USER FINISHED THE PROCEDURE WITH ANOTHER NEW DEVICE. THE SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6576602 ↗