Flexor G09601Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002096011), received between Feb 26, 2015 and Sep 4, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A FLEXOR INTRODUCER SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. THERE WERE NO SERIOUS CONSEQUENCES FOR THE PATIENT OR USER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22966152 ↗
• MalfunctionJul 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654620 ↗
• MalfunctionOct 25, 2021Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692580 ↗
• MalfunctionJul 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CHECK-FLO VALVE OF A FLEXOR INTRODUCER SHEATH SEPARATED FROM THE DEVICE DURING A RIGHT EXTERNAL ILIAC RECANALIZATION. ACCESS WAS GAINED IN THE RIGHT COMMON FEMORAL ARTERY TARGETING THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT DID NOT HAVE ANY TORTUOUS, CALCIFIED, OR SCARRED ANATOMY. THE DEVICE WAS USED OVER A 0.035 INCH AMPLATZ WIRE GUIDE. DURING RETRIEVAL OF THE DEVICE, THE CHECK-FLO VALVE DETACHED FROM THE DEVICE. RESISTANCE WAS NOT FELT DURING REMOVAL. THE DEVICE WAS PULLED BY THE HUB DURING REMOVAL, AND THE DILATOR WAS NOT IN PLACE. ANOTHER 9FR INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12225618 ↗
• InjurySep 27, 2017Detachment Of Device Component; Kinked; Split; Detachment Of Device Component; Kinked; Split

  A FLEXOR INTRODUCER SHEATH WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, DURING THE PROCEDURE, THE TIP OF THE INTRODUCER DETACHED. AS A RESULT, THE ENTRY POINT WAS ENLARGED AND THE PATIENT HAD EXCESSIVE BLOOD LOSS AND HAD TO BE RESUSCITATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: Blood Loss

  MAUDE report 6897354 ↗
• MalfunctionOct 3, 2016Break; Break

  IT WAS REPORTED THAT DURING A FEMORAL ACCESS PROCEDURE ON A (B)(6) MALE LED PATIENT, THE FLEXOR INTRODUCER SHEATH DEVICE BROKE BETWEEN THE DESILET AND THE INTRODUCER. THE PATIENT REPORTEDLY HAD A TORTUOUS/CALCIFIED ANATOMY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. 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 5993773 ↗
• MalfunctionFeb 26, 2015Material Separation; Difficult to Advance

  WHILE ATTEMPTING TO PERFORM A CROSSOVER PROCEDURE OVER THE SUPERFICIAL FEMORAL ARTERY, THE ROTAREX DID NOT PUSH OVER THE BIFURCATION THROUGH THE 8 F INTRODUCER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICES, THE CHECK FLO VALVES OF BOTH SHEATHS RIPPED WHILE PULLING OUT THE INTRODUCERS. THE PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A TERUMO INTRODUCER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DEU TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4577509 ↗