Flexor G32233Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002322332), received between Apr 13, 2016 and Nov 11, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0993-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionNov 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A HAIR WAS DISCOVERED INSIDE THE FLEXOR GUIDING SHEATH'S SEALED PACKAGE. THE PROCEDURE WAS NOT DELAYED AS ANOTHER OF THE SAME-TYPE SHEATH WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654073 ↗
• MalfunctionDec 18, 2023Break; Peeled/Delaminated; Unraveled Material; Break; Peeled/Delaminated; Unraveled Material

  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 18350072 ↗
• MalfunctionMar 29, 2022Unraveled Material; Unraveled Material

  AS REPORTED, AT THE END OF A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, A FLEXOR GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE FROM THE PATIENT, AND THE SHEATH'S INNER COIL UNRAVELED. THE DEVICE, WHICH DID NOT FULLY SEPARATE, WAS REMOVED FROM THE PATIENT INTACT. 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 13940744 ↗
• MalfunctionJun 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913722 ↗
• MalfunctionFeb 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A LIVER BIOPSY VIA TRANSJUGULAR ACCESS, THE HUB OF A FLEXOR GUIDING SHEATH LEAKED. AN UNKNOWN WIRE WAS IN THE LUMEN OF THE DEVICE AT THE TIME THE LEAK OCCURRED. ANOTHER SHEATH 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 Consequences Or Impact To Patient

  MAUDE report 9711114 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  CUSTOMER REPORTED THAT A MALE PATIENT UNDERWENT A TRANSJUGULAR LIVER BIOPSY. AFTER INITIAL PLACEMENT OF THE DEVICE, THE ATTENDING PHYSICIAN RETRACTED THE DEVICE AND ATTEMPTED TO CURVE THE TIP. THE DILATOR WAS IN THE SHEATH WHILE CURVING THE DEVICE. THE DISTAL TIP OF THE DILATOR SEPARATED WHILE IT WAS OUTSIDE OF THE PATIENTS BODY. 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 6291275 ↗
• MalfunctionApr 13, 2016Component Missing; Component Missing

  A PATIENT OF UNKNOWN GENDER AND AGE WAS UNDERGOING A TIPS PROCEDURE. UTILIZING INTERMITTENT FLUOROSCOPIC GUIDANCE, THE SHEATH WAS ADVANCED INTO THE RIGHT ATRIUM. AT THIS POINT IT WAS NOTED THAT THE SHEATH DID NOT HAVE A RADIOPAQUE BAND TO MARK WHERE THE SHEATH ENDED. 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 5573157 ↗