Flexor G49570Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002495708), received between Aug 29, 2017 and Dec 9, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2019Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING A PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE, AND DIABETES MELLITUS, A FLEXOR INTRODUCER SHEATH DILATOR SEPARATED AS THE PHYSICIAN WAS REMOVING THE DILATOR FROM THE SHEATH OVER A 0.035 INCH HI-WIRE. THE PATIENT'S ANATOMY WAS REPORTEDLY CALCIFIED WITHIN THE COMMON FEMORAL ARTERY AND AT THE BIFURCATION. 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 Consequences Or Impact To Patient

  MAUDE report 9437831 ↗
• MalfunctionApr 22, 2019Detachment 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 Consequences Or Impact To Patient

  MAUDE report 8536948 ↗
• InjuryDec 4, 2018Material Separation; Material Separation

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

  Patient problems: No Code Available

  MAUDE report 8129794 ↗
• 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 6950467 ↗
• InjuryAug 29, 2017Material Separation; Material Separation

  ACCORDING TO THE TRANSLATED PRODUCT COMPLAINT PROVIDED BY THE INTERNATIONAL CUSTOMER, AN AFCD ECHO-GUIDED PUNCTURE WAS PERFORMED IN THE RIGHT COMMON FEMORAL ARTERY OF A PATIENT USING A FLEXOR INTRODUCER SHEATH. INITIALLY, AN UNKNOWN 0.035 WIRE GUIDE WAS INSERTED WITH SOME DIFFICULTY. DESPITE AN INCISION IN THE SKIN, THE 5FR 45CM FLEXOR INTRODUCER SHEATH WAS HAVING DIFFICULTY BEING INSERTED AS WELL. AN UNSPECIFIED 5FR 10CM SHEATH WAS THEN INSERTED WITHOUT PROBLEM. AFTER AN UNSPECIFIED AMPLATZ GUIDE WAS INSERTED, AND THE FLEXOR INTRODUCER SHEATH COULD SUCCESSFULLY PROGRESS IN THE VESSEL. HOWEVER, A SENSATION OF RESISTANCE AT THE PASSAGE OF THE SKIN WAS FELT. THE AMPLATZ GUIDE WAS HELD IN POSITION AS THE FLEXOR INTRODUCER SHEATH WAS REMOVED UPON COMPLETION OF THE PROCEDURE. IT WAS REPORTED THAT AS THE SHEATH WAS BEING REMOVED, THE TUBING OF THE SHEATH SEPARATED THREE TIMES, EACH REVEALING THE COILING WITHIN THE DEVICE. AS THE PHYSICIAN CONTINUED TO APPLY FORCE WHILE REMOVING THE FLEXOR INTRODUCER SHEATH, THE COILING SEPARATED AND A 4-CM PIECE OF THE DEVICE REMAINED INSIDE THE PATIENT. UNDER LOCAL ANESTHESIA, THE DEVICE WAS ABLE TO BE REMOVED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 6826821 ↗