GORE DRYSEAL FLEX Introducer Sheath DSF1865Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132628346), received between Sep 26, 2022 and Jul 7, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K160254); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Fluid/Blood Leak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. AFTER INSERTION OF THE 18FR SHEATH INTO THE PATIENT, BLOOD LEAKAGE FROM THE DRYSEAL VALVE WAS OBSERVED UPON REMOVAL OF THE DILATOR. AS THE BLEEDING CONTINUED, THE DEVICE WAS REPLACED WITH AN ALTERNATIVE, AND THE PROCEDURE WAS CONTINUED. NO HEMODYNAMIC DETERIORATION OR BLOOD TRANSFUSION ATTRIBUTABLE TO THIS BLEEDING WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729869 ↗
• MalfunctionFeb 22, 2026Material Perforation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026 A GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF 1865 WAS USED TO PERFORM THROMBECTOMY IN A PATIENT WITH PULMONARY EMBOLISM. DURING THE PROCEDURE, BLOOD WAS REPORTEDLY NOTED LEAKING THROUGH THE SHEATH VALVE AS IF IT WERE PERFORATED BUT NO LEAKAGE WAS OBSERVED DURING DEVICE PREPARATION. REPORTEDLY, BLOOD LOSS WAS LESS THAN ONE LITER AND THERE WAS NEITHER HEMODYNAMIC IMPAIRMENT NOR WAS A BLOOD TRANSFUSION ADMINISTERED. IT WAS ADDITIONALLY REPORTED THAT VALVE RE-PRESSURIZATION WAS ATTEMPTED BUT WOULD NOT STOP THE BLEEDING. HOWEVER, THE PHYSICIAN WAS REPORTEDLY ABLE TO CONCLUDE THE PROCEDURE WITHOUT REPLACING THE SHEATH. NO INFORMATION WAS AVAILABLE AS TO THE CAUSE OF THE SUSPECTED SHEATH VALVE PERFORATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24410977 ↗
• InjuryMar 19, 2024Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TAVI PROCEDURE. GORE® DRYSEAL FLEX INTRODUCER SHEATHS WERE USED FOR THIS PROCEDURE. A 14FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FIRST AND A BALLOON INFLATION WAS DONE. THEN, A 14FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS CHANGED TO A 18FR ONE AND TAVI WAS CONCLUDED WITHOUT ANY ISSUE. WHEN THE 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS REMOVED, THE RADIOPAQUE MARKER REMAINED IN THE EXTERNAL ILIAC ARTERY. THE RADIOPAQUE MARKER WAS SEPARATED FROM THE SHEATH. IT WAS CONSIDERED THAT THE RADIOPAQUE MARKER WOULD BE REMOVED USING A SNARE CATHETER, BUT FINALLY THE RADIOPAQUE MARKER WAS REMOVED SUCCESSFULLY BY CUT DOWN. IT WAS REPORTED THAT THE THORACIC WAS TORTUOUS BUT IT DIDN¿T FEEL STRONG RESISTANCE OR DIFFICULTY WHEN A DEVICE ADVANCED AND/OR REMOVED AND THE SHEATH REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 18927807 ↗
• MalfunctionDec 4, 2023Material Separation; Material Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) FOR HEART VALVE DISEASE. THE DSF WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. AFTER ADVANCING THE DSF TO THE ARCH TOP USING THE PROXIMAL MARKER AS A GUIDE, A NON-GORE VALVE (EVOLUT) WAS INSERTED. BECAUSE THE DSF WAS DEEP, UNSHEATHING WAS ATTEMPTED. THEN, THE PROXIMAL MARKER DID NOT MOVE, AND SEPARATION OF THE DSF TIP WAS SUSPECTED. AFTER REMOVING THE EVOLUT, A NON-GORE BALLOON CATHETER MADE WAS INSERTED. THE BALLOON WAS INFLATED WITHIN THE SEPARATED PORTION AND MOVED TO GROIN REGION. CUT DOWN WAS PERFORMED AND THE SEPARATED PORTION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DSF. THE PHYSICIAN STATED THE FOLLOWING. THE COMMON ILIAC ARTERY WAS PARTIALLY CALCIFIED, AND THERE WAS SOME RESISTANCE WHEN INSERTING THE SHEATH, BUT THERE WAS NO RESISTANCE WHEN INSERTING EVOLUT.

  Patient problems: Insufficient Information

  MAUDE report 18261146 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) AS AN ACCESSORY IN THE PROCEDURE. IT WAS NOTED THAT A GORE REPRESENTATIVE WAS NOT PRESENT AT THE CASE AS IT WAS NOT A GORE CASE. HOWEVER, THE INFORMATION WAS REPORTED TO THE GORE REPRESENTATIVE ON JUNE 20, 2023, BY A PENUMBRA REPRESENTATIVE WHO WAS PRESENT IN THE CASE. IT WAS REPORTED THAT A PENUMBRA LIGHTNING FLASH DEVICE WAS BEING USED IN CONJUNCTION WITH THE 18FR. DSF. THERE WERE NO ISSUES REPORTED DURING ADVANCEMENT, USE, OR WITHDRAWAL OF THE NON-GORE DEVICE. AFTER THE PROCEDURE WAS COMPLETED, THE 18FR. DSF WAS BEING REMOVED FROM THE PATIENT WHEN IT WAS REPORTEDLY OBSERVED THAT THE DSF RADIOPAQUE MARKER BAND HAD BROKEN AWAY FROM THE SHEATH AT THE PATIENT'S ACCESS SITE. NO TORTUOSITY WAS REPORTED TO HAVE CONTRIBUTED TO THE EVENT AND THE CAUSE OF THE MARKER BAND BREAK WAS UNKNOWN. THE RADIOPAQUE MARKER BAND WAS LEFT IN THE PATIENT. THERE WAS NO REPORTED CLINICAL SEQUALAE AT THE CLOSE OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746674 ↗
• MalfunctionSep 26, 2022Break; Break

  ON (B)(6) 2022, THIS PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI) FOR A VALVULAR HEART DISEASE USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). BEFORE INSERTING THE DELIVERY CATHETER, A BALLOON CATHETER (Z-MEDII, PDZ652) WAS ADVANCED THROUGH THE DSF AND BALLOON EXPANSION OF THE AORTIC VALVE WAS PERFORMED. THE BALLOON WAS GETTING IN AND OUT OF THE DSF FOR 3 TIMES DURING THIS STEP. THEREAFTER THE PHYSICIAN NOTICED THAT THE MARKER ON THE LEADING TIP WAS SEPARATED FROM THE DSF WHEN HE WAS WITHDRAWING IT. THE DSF WAS WITHDRAWN AND ANOTHER DSF (DSF1833) WAS USED FOR THE REST OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. THE DEVICE WAS RETURNED TO GORE FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION WAS RECEIVED VIA THE FSA ON AUGUST 30, 2022, AS FOLLOWS. TAVI WAS PERFORMED VIA THE RIGHT FEMORAL APPROACH (CUT-DOWN). THE DSF WAS INSERTED OVER A STIFF-TYPE GUIDEWIRE (SAFARI). THE DSF WAS ADVANCED TO THE LEVEL WHERE THE DSF TIP WAS JUST PROXIMAL TO THE ARCH, AND THE SAFARI WAS INSERTED IN THE LEFT VENTRICLE. WHEN ADVANCING THE WIRE, THE DSF WAS MOVED A LITTLE DISTALLY. THEREFORE, THE PHYSICIAN INSERTED THE DILATOR AND

  Patient problems: Valvular Stenosis

  MAUDE report 15482762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160254. One submission often covers many models, so check the product and lot details in each record.

• Z-1962-2020 · Nov 18, 2019 · Terminated
  Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.