Flexor G09809Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002098091), received between Oct 14, 2017 and Mar 14, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE LASER ATHERECTOMY CATHETER AND 0.014-INCH WIRE GUIDE WERE IN THE LUMEN OF THE DEVICE WHEN THE SHEATH SEPARATED AT THE LEVEL OF THE HUB. CORRECTION: THE USER ATTEMPTED TO ADVANCE THE SHEATH AND LASER ATHERECTOMY CATHETER AS A UNIT, OVER THE WIRE GUIDE; HOWEVER, ADVANCEMENT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538521 ↗
• MalfunctionSep 24, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525714 ↗
• MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11284931 ↗
• MalfunctionApr 4, 2019Material Separation; Material Separation

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE, FLEXOR INTRODUCER SHEATH WAS USED. THE FACILITY REPORTED THAT THE SHEATH SEPARATED IN THE PATIENT. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. ACCORDING TO THE INITIAL REPORTER, THE COMPLAINT DEVICE IS BEING RETAINED BY THE FACILITY AND WILL NOT BE MADE AVAILABLE FOR THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Vascular Dissection

  MAUDE report 8483580 ↗
• MalfunctionMar 29, 2018Material Separation; Material Separation

  PER SUS VOLUNTARY MW5074769, "FLEXOR INTRODUCER SHEATH INSERTED INTO RIGHT FEMORAL ARTERY, SHEATH CAME APART. HUB CAME DETACHED FROM SHEATH BODY."ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381703 ↗
• MalfunctionFeb 5, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANTEROGRADE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BELOW THE KNEE (BTK) WITH A DRUG-ELUTING BALLOON (DEB), THE FLEXOR INTRODUCER WAS INSERTED WITHOUT DIFFICULTY. ANOTHER MANUFACTURER'S THREE (3) MILLIMETER (MM) DIAMETER, 120 MM LENGTH BALLOON CATHETER WAS ADVANCED OVER A WIRE GUIDE (OTHER MANUFACTURER). THE BALLOON CATHETER UTILIZED HAS A PROTECTIVE SLEEVE OVER THE DRUG-COATED BALLOON; THE BALLOON WAS REQUIRED TO BE INSERTED INTO THE INTRODUCER WITH THE SLEEVE. AS THE PHYSICIAN PULLED THE SLEEVE FROM THE INTRODUCER WITH THE BALLOON STILL IN PLACE, THE ELASTIC PORTION ON THE INTRODUCER VALVE DID NOT CLOSE AND BLOOD SPURTED OUT. THE PHYSICIAN EXCHANGED THE INTRODUCER WITH ANOTHER FLEXOR INTRODUCER AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT ANOTHER MANUFACTURER'S 0.035 INCH DIAMETER WIRE GUIDE WAS UTILIZED THROUGH THE SHEATH PRIOR TO USE OF THE BALLOON CATHETER AND AFOREMENTIONED WIRE GUIDE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE TOOK LONGER; HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7240802 ↗
• MalfunctionOct 25, 2017Material Separation; Material Separation

  A FLEXOR INTRODUCER SHEATH WAS BEING USED IN AN ABDOMINAL-AORTOGRAM RUN-OFF PROCEDURE VIA CONTRALATERAL APPROACH AND PLACED IN THE LEFT COMMON FEMORAL ARTERY. IT WAS REPORTED THAT, THE PHYSICIAN PUT THE DILATOR INTO THE SHEATH BEFORE REMOVING IT AND WHEN PULLING OUT THE SHEATH IT SNAPPED IN TWO. WHEN THE SHEATH SEPARATED IT STAYED ON THE DILATOR AND WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENTS ANATOMY WAS REPORTEDLY NOT TORTUOUS OR CALCIFIED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 6978419 ↗
• MalfunctionOct 14, 2017Material Separation; Material Separation

  A FLEXOR INTRODUCER SHEATH WAS USED DURING A SUPERFICIAL FEMORAL ARTERY PROCEDURE VIA CONTRALATERAL ACCESS. IT WAS REPORTED THAT THE HUB SEPARATED FROM THE SHEATH DURING REMOVAL. A WIRE GUIDE WAS BEING USED; HOWEVER, THEY DID NOT USE A DILATOR. THE SHEATH AND HUB WERE REMOVED AND REPLACED WITH A SHORT SHEATH, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 6950466 ↗