Flexor G13081Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002130814), received between Apr 2, 2018 and Dec 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE INTERNAL WIRE OF A FLEXOR RTPS GUIDING SHEATH UNRAVELED DURING USE, WHICH PREVENTED CONTINUATION OF THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. MULTIPLE STENTS WERE LOST AS A RESULT, AND THE PROCEDURE HAD TO BE RESTARTED AFTER REMOVAL OF THE AFFECTED ACCESS SHEATH. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864839 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN UNKNOWN STENT COULD NOT BE ADVANCED THROUGH A FLEXOR RTPS GUIDING SHEATH. THE DEVICE WAS RETURNED TO COOK, AND TIP DAMAGE WAS DISCOVERED, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21171011 ↗
• MalfunctionAug 1, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  UPON DEVICE FAILURE ANALYSIS OF THE RETURNED COMPLAINT DEVICE, IT WAS DETERMINED THE SHEATH UNRAVELED. THE SHEATH APPEARED TO BE PULLED THROUGH THE HUB WITH THE DILATOR AND THE COILS OF THE SHEATH WERE EXPOSED. NO OTHER DAMAGE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438104 ↗
• MalfunctionNov 22, 2022Difficult to Insert; Material Separation; Difficult to Insert; Material Separation

  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 15846827 ↗
• MalfunctionJan 26, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A FLEXOR RTPS GUIDING SHEATH MALFUNCTIONED. DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, THE USER ATTEMPTED TO FLUSH THE DEVICE WITHOUT SUCCESS. SUBSEQUENTLY, THE SHEATH WAS REMOVED AND REPLACED WITH A LIKE DEVICE. UPON RETURN OF THE COMPLAINT DEVICE ON 11JAN2022, IT WAS NOTED THAT THE SHEATH WAS UNRAVELED AND SEPARATED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

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

  MAUDE report 13358734 ↗
• MalfunctionJun 23, 2020Leak/Splash; Leak/Splash

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10185152 ↗
• MalfunctionFeb 27, 2020Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, A FIBER WAS OBSERVED ON A FLEXOR RTPS GUIDING SHEATH AT THE END OF A PROCEDURE TO REMOVE AN UNSPECIFIED INFERIOR VENA CAVA FILTER. UPON RETURN AND INVESTIGATION OF THE DEVICE, A DETACHED STRING OF THE TNRT LINER WAS FOUND. 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 9765399 ↗
• MalfunctionJun 24, 2019Material Separation; Material Separation

  IT WAS REPORTED A FLEXOR RTPS GUIDING SHEATH WAS USED IN AN UNKNOWN PATIENT FOR AN INFERIOR VENA CAVA FILTER REMOVAL. AS REPORTED, DURING THE ATTEMPTED REMOVAL OF THE SHEATH THE "MARKER TIP CAME OFF OF THE SHEATH AND WENT INSIDE THE SHEATH...EVERYTHING WAS REMOVED SUCCESSFULLY AT ONE TIME." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726539 ↗
• MalfunctionApr 2, 2018Split; Split

  THE CUSTOMER REPORTED THAT, WHEN THE PACKAGE OF THE FLEXOR RTPS GUIDING SHEATH WAS OPENED FOR A TRANSJUGULAR LIVER BIOPSY, IT WAS DISCOVERED THAT THE DILATOR THAT WAS INCLUDED WITH THE INTRODUCER HAD AN IRREGULAR TIP; THERE APPEARED TO BE A SPLIT IN THE TIP OF THE DEVICE. THE OPERATOR ATTEMPTED TO INTRODUCE IT THROUGH THE SKIN OF THE PATIENT, BUT SUBSEQUENTLY RAN INTO UNSPECIFIED DIFFICULTIES. THE OPERATOR REPLACED THE PRODUCT WITH A NEW DEVICE, AND NO FURTHER ISSUES WERE REPORTED. NO ANATOMICAL ABNORMALITIES WERE NOTED AT THE ACCESS SITE. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM, AND NO ADDITIONAL PROCEDURES WERE NECESSITATED. THE COMPLAINT DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390814 ↗