GORE® DrySeal Flex Introducer Sheath GDSF1833Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132658978), received between Jan 8, 2026 and Aug 7, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Material Separation

  The following was reported to Gore:On (b)(6), 2026, the patient underwent endovascular reintervention for a type IA endoleak ((b)(4)). An 18 Fr GORE® DrySeal Flex Introducer Sheath was used during the procedure.It was reported that the patient had undergone multiple prior open groin procedures and had significant scar tissue within the tissue tracts. Placement of the sheath was initially attempted through the right femoral access but was unsuccessful due to resistance. The sheath was subsequently inserted through the left femoral access with significant force.The treatment devices were delivered successfully. However, it was reported that during removal of the sheath over a Lunderquist guidewire, significant resistance was encountered at the arteriotomy, and substantial force was required. The sheath reportedly began to accordion and stretch, and its coil reinforcement became exposed and was visible around the guidewire. After removal of the sheath and guidewire, fluoroscopy showed that the radiopaque marker from the distal end of the sheath remained in the patient.The physician performed a common femoral artery cutdown because the marker was suspected to be extravascular within th

  Patient problems: Foreign Body In Patient

  MAUDE report 50175189 ↗
• InjuryApr 20, 2026Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (18FR) AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING PREPARATION FOR STENT GRAFT INSERTION, SEPARATION OF THE METAL STYLET AND OLIVE TIP WAS NOTED. THE OLIVE TIP WAS FOUND TO BE SLIGHTLY MORE SEPARATED THAN NORMAL. THE COMPONENTS WERE MANUALLY REPOSITIONED, AND THE OLIVE TIP APPEARED INTACT AND IN NORMAL ALIGNMENT. THE DEVICE WAS THEN INSERTED INTO THE DRYSEAL SHEATH. SHORTLY THEREAFTER, BLOOD WAS OBSERVED GUSHING FROM THE SHEATH, INDICATING LOSS OF HEMOSTASIS AND POSSIBLE PUNCTURE OF THE SHEATH BLADDER WITH THE DEVICE WITHDRAWN. THERE WAS ALSO CONCERN THAT A POSTERIOR NITINOL WIRE FROM THE STENT GRAFT HAD BECOME EXPOSED OR DISPLACED, LIKELY DURING MANIPULATION. THE NITINOL WIRE IS BELIEVED TO HAVE PUNCTURED THE DRYSEAL SHEATH BLADDER, CONTRIBUTING TO LOSS OF HEMOSTASIS. DURING THE INITIAL INSPECTION OF THE GRAFT PACKAGING SUGGESTED THE GRAFT APPEARED SLANTED TO ONE SIDE, ALTHOUGH NO DEPLOYMENT ISSUES WERE IDENTIFIED. IT WAS SUSPECTED THAT THE STYLET MAY HAVE BEEN BENT DURING DEVICE MANIPULA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24927455 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON FEBRUARY 9, 2026 FROM A TGR ALERT NOTIFICATION: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR A COMMON ILIAC AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH THE GORE® DRYSEAL FLEX INTRODUCER SHEATHS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE ENDOVASCULAR ACCESS METHOD ON THE RIGHT WAS PERCUTANEOUS AND ON THE LEFT WAS BY CUT-DOWN. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THERE WERE NO ACCESS-RELATED COMPLICATIONS. DURING THE INDEX PROCEDURE, AN ADJUNCTIVE COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY WAS PERFORMED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED LEFT GROIN INCISION CELLULITIS. THE PATIENT WAS GIVEN ANTIBIOTICS AS A TREATMENT. THE PATIENT WAS NOTED TO BE RECOVERED/RESOLVED WITHOUT SEQUELAE ON (B)(6) 2025. THE INFECTION WAS AT THE ACCESS SITE; HOWEVER, THE INFECTION WAS NOT RELATED TO ANY GORE DEVICE USED/IMPLANTED. THE PHYSICIAN STATED THE CAUSE OF THE CELLULITIS WAS SURGICAL SITE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24498022 ↗
• MalfunctionJan 8, 2026Difficult to Insert; Mechanical Problem; Difficult to Remove; Insufficient Device Problem Information

  THIS REPORT WAS SENT AS A RETRACTION. BASED ON THE ENGINEERING FINDINGS, THERE WERE NO DISCREPANCIES NOTED WITH THE LOCKING MECHANISMS OF THE SHEATH AND DILATOR. THE ONLY ISSUE FOUND WAS THAT THE DILATOR TIP HAD A BEND. THESE FINDINGS WOULD INDICATE TO BE A NOT-REPORTABLE SHEATH EVENT AS THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE MALFUNCTION OR A SERIOUS INJURY. AS NO DEATH, SERIOUS INJURY, OR MALFUNCTION HAS OCCURRED, SO THIS EVENT IS NOT REPORTABLE TO FDA.

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

  MAUDE report 24016454 ↗

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.