XEN Glaucoma Treatment System 5513-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 10888628032439), received between May 15, 2020 and Sep 11, 2026 — classified as 179 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (72 reports).

1 other recall cover devices cleared under the same FDA submission (K161457); 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 25 most recent of 280 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Physical Resistance/Sticking

  Healthcare Professional reported a XEN®45 GTS "implant protruding with a stiff slider.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736585 ↗
• MalfunctionSep 11, 2026Delivered as Unsterile Product

  Additionally, Healthcare Professional reported device did not make patient contact. Surgery was completed with backup device in right eye.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736582 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reporting a XEN®45 GTS was implanted in the left eye. Postoperatively, patient experienced "pain, tearing, and a foreign body sensation; which have worsened since implantation." On POD992, patient underwent trabeculectomy. On POD1196, HCP noted "fairly extensive hypertrophic filtration bleb located nasally in the interpalpebral area" is probable cause for discomfort and explanted the device.

  Patient problems: Eye Injury; Glaucoma

  MAUDE report 50085944 ↗
• MalfunctionJul 27, 2026Mechanical Jam

  Healthcare Professional reported a XEN®45 GTS "injector slider would not advance" during implantation in left eye. Surgery was completed with backup device. No eye injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009565 ↗
• MalfunctionJun 22, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "SLIDER MALFUNCTION." DEVICE DID NOT MAKE PATIENT CONTACT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586061 ↗
• MalfunctionMay 13, 2026Mechanical Jam

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "JAMMED AND WOULD NOT DEPLOY PRIOR TO PATIENT CONTACT." SURGERY WAS COMPLETED WITH BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162344 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  THE ARTICLE "COMPARISON OF CLINICAL OUTCOMES BETWEEN XEN GEL STENT AND PRESERFLO MICROSHUNT: A MONOCENTRIC EXPERIENCE" NOTED 31 EYES WERE IMPLANTED WITH A XEN 45 GEL STENT AND EXPERIENCED ADVERSE EVENTS INCLUDING 2 EYES EXPERIENCED EARLY HYPOTONY THAT WAS SELF RESOLVING; 1 EYE EXPERIENCED HYPHEMIA THAT WAS SELF RESOLVING; AND 12 EYES EXPERIENCED FILTERING BLEB FIBROSIS. OF THESE 12, 11 EYES REQUIRED NEEDLING WITH 5-FLUOROURACIL, 3 EYES REQUIRED BLEB REVISION SURGERY WITH MMC 0.02%, AND 4 EYES REQUIRED A FURTHER GLAUCOMA SURGERY CONSISTING OF EITHER A TRABECULECTOMY OR IMPLANTATION OF ANOTHER GLAUCOMA VALVE.

  Patient problems: Fibrosis; Hyphema; Intraocular Pressure Decreased; Intraocular Pressure Increased

  MAUDE report 24971984 ↗
• MalfunctionMar 25, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "WOULD NOT ADVANCE CORRECTLY." DEVICE DID NOT MAKE PATIENT CONTACT. SURGERY WAS COMPLETED WITH BACKUP DEVICE IN THE RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688571 ↗
• MalfunctionMar 13, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "UNABLE TO MOVE SMOOTHLY AND STUCK WHEN TRYING TO DEPLOY" IN LEFT EYE. SURGERY WAS COMPLETED WITH BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598468 ↗
• MalfunctionMar 13, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "UNABLE TO MOVE SMOOTHLY AND STUCK WHEN TRYING TO DEPLOY" IN LEFT EYE. SURGERY WAS COMPLETED WITH BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594967 ↗
• MalfunctionMar 13, 2026Physical Resistance/Sticking

  Healthcare Professional reported a XEN®45 GTS "unable to move smoothly and stuck when trying to deploy" in left eye. Surgery was completed with backup device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592604 ↗
• MalfunctionMar 13, 2026Retraction Problem

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "NEEDLE TIP DID NOT RETRACT WITH MECHANISM." DEVICE DID NOT MAKE PATIENT CONTACT. SURGERY WAS COMPLETED WITH BACKUP DEVICE IN RIGHT EYE. NO EYE INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592566 ↗
• InjuryMar 10, 2026

  I HAD AN XEN GEL STENT IMPLANTED IN MY LEFT EYE IN (B)(6) 2025. ON (B)(6) 2025, I WOKE WITH MY LEFT EYE IRRITATED. AROUND 10 AM I CONTACTED THE SURGEON THAT IMPLANTED THE STENT AND MADE AN APPOINTMENT AT 1PM THAT DAY. AT THAT APPOINTMENT, THE SURGEON REMOVED A PART OF THE XEN GEL STENT FROM MY EYE AND TOLD ME THAT THE STENT HAD BROKEN AND POKED INTO THE WHITE OF MY EYE AND I HAD AN INFECTION. HE TOLD ME THAT HE WAS GOING TO PRESCRIBE ORAL ANTIBIOTICS AND DROPS FOR MY EYES BUT THAT I MAY HAVE TO HAVE ANTIBIOTIC INJECTIONS INTO MY EYE. I MADE A FOLLOW UP APPOINTMENT FOR (B)(6) 2025 AT 3:40PM. DURING THE NIGHT THE PAIN IN MY EYE GOT WORSE AND I BEGAN TO VOMIT AND DRY HEAVE. THE NEXT MORNING MY HUSBAND CALLED THE SURGEON'S OFFICE AND TOLD THEM THAT I WAS IN A LOT OF PAIN AND WAS VOMITING. THE SURGEON OFFERED TO CALL IN NAUSEA MEDS BUT I COULD NOT KEEP ANYTHING DOWN. MY HUSBAND BROUGHT ME TO THE LOCAL EMERGENCY ROOM WHERE THEY GAVE ME PAIN MED AND IV FLUIDS. AT 340PM THAT AFTERNOON I WENT TO MY APPOINTMENT WITH THE SURGEON. DURING THE EXAMINATION, THE SURGEON DETERMINED THAT I HAD LOST ALL VISION IN MY LEFT EYE. HE REFERRED ME TO A RETINA SPECIALIST WHO GAVE ME SEVERAL ANTIBIOTIC INJECT

  Patient problems: Eye Infections; Eye Irritation; Loss of Vision; Nausea; Pain; Vomiting

  MAUDE report 24560372 ↗
• MalfunctionMar 5, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "SLIDER CATCHING, WOULDN'T ADVANCE SMOOTHLY." HCP REPORTED DEVICE DID NOT MAKE PATIENT CONTACT. SURGERY WAS COMPLETED WITH BACKUP DEVICE. NO EYE INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515544 ↗
• MalfunctionMar 5, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "INJECTOR WAS CATCHING AND NOT EJECTING" DURING IMPLANTATION IN RIGHT EYE. SURGERY WAS COMPLETED WITH BACKUP DEVICE. NO EYE INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515218 ↗
• MalfunctionMar 4, 2026Mechanical Jam

  HEALTHCARE PROFESSIONAL REPORTED DURING ATTEMPTED IMPLANTATION OF A XEN®45 GTS INTO THE RIGHT EYE, THAT THE "SLIDER MALFUNCTIONED". THERE WAS NO INJURY TO THE PATIENT AND A BACKUP DEVICE WAS USED TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508607 ↗
• MalfunctionMar 2, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED THAT ONE XEN®45 GTS GEL STENT "WOULD NOT ADVANCE CORRECTLY". THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. SURGERY COMPLETED WITH A BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484436 ↗
• MalfunctionFeb 18, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "IMPLANT BROKEN DUE TO DEFECTIVE SLIDER" DURING IMPLANTATION IN LEFT EYE. DEVICE AVAILABLE FOR RETURN. SURGERY WAS COMPLETED WITH SECOND XEN®45 GTS DEVICE. NO EYE INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379585 ↗
• InjuryFeb 16, 2026Complete Blockage; Material Twisted/Bent; Migration

  THE ARTICLE "OUTCOMES OF THE 63-M GELATIN MICROSTENT VERSUS 45-M GELATIN MICROSTENT: AN INTERNATIONAL MULTI-CENTER STUDY" NOTED PATIENTS IMPLANTED WITH THE XEN 45 GEL STENT EXPERIENCED ADVERSE EVENTS INCLUDING 45 EYES WERE NOT CONSIDERED A QUALIFIED SUCCESS AT THE END OF THE 12 MONTH FOLLOW UP (IOP GREATER THAN 21MMHG); 2 EYES EXPERIENCED A POSITIVE SEIDEL; 5 EYES EXPERIENCED AN ENCAPSULATED BLEB; 11 EYES EXPERIENCED A SHALLOW AC; 1 EYE EXPERIENCED IRIDOCORNEAL TOUCH; 6 EYES EXPERIENCED CHOROIDALS; 6 EYES EXPERIENCED HYPHEMA; 4 EYES EXPERIENCED IRITIS; 2 EYES EXPERIENCED DELLEN; 2 EYES EXPERIENCED VITREOUS HEMORRHAGE; 2 EYES EXPERIENCED MACULAR EDEMA; 15 EYES EXPERIENCED A BLOCKED XEN DEVICE; 2 EYES EXPERIENCED A XEN-CORNEA TOUCH; 7 EYES EXPERIENCED A XEN-IRIS TOUCH; 1 EYE EXPERIENCED A MIGRATED XEN; 3 EYES EXPERIENCED A BENT XEN; 1 EYE EXPERIENCED CORNEAL DECOMPENSATION WITH UNDERLYING ENDOTHELIAL DYSFUNCTION. PATIENT UNDERWENT DESCEMET'S STRIPPING ENDOTHELIAL KERATOPLASTY; 1 EYE EXPERIENCED MALIGNANT GLAUCOMA. PATIENT UNDERWENT AN IRIDOZONULOVITRECTOMY; AND 18 EYES TOTAL REQUIRED NEEDLING, 13 WITH ANTIMETABOLITE, 5 WITHOUT. ADDITIONAL INTERVENTIONS WERE ALSO CARRIED OUT INCLUDING

  Patient problems: Corneal Decompensation; Eye Injury; Glaucoma; Intraocular Pressure Increased; Keratitis

  MAUDE report 24347882 ↗
• MalfunctionFeb 16, 2026Physical Resistance/Sticking

  ADDITIONAL INFORMATION REPORTED THE INJECTOR HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345089 ↗
• InjuryFeb 12, 2026Fracture; Device Appears to Trigger Rejection

  (B)(6) REPORTED THEY UNDERWENT XEN®45 GTS IMPLANTATION VIA AB-EXTERNO IN LEFT EYE. POD1, HCP REPORTED SHALLOW BLEB; WHICH RESOLVED ON POD6. POST-OPERATIVE MONTH EIGHT, PATIENT REPORTED EYE BECAME RED AND ITCHY, MODERATE PAINFUL EYE, BLURRED VISION, HEADACHE, PHOTOPHOBIA, RED EYE, SWELLING IN EYELID, TEARING, AND JAW PAIN. ON POD239, HCP DIAGNOSED ENDOPHTHALMITIS AND SLIT LAMP EXAMINATION SHOWED BROKEN XEN AND XEN ERODED THROUGH CONJUNCTIVA; PROVIDED TREATMENT OF MOXI. Q1, PRED. QID, DIAMOX 250 BID, AND LEVAQUIN 750 QD. ON POD240, ENDOPHTHALMITIS IS WORSE, LOSS OF PERIPHERAL VISION, BLURRED VISION, PAIN, EYE REDNESS, NAUSEA, AND VOMITING; SLIT LAMP SHOWED CORNEA EDEMA. LATER ON POD240, TREATING HCP NOTED THEY COULD NOT SEE THE STENT AND PROVIDED INTRAVITREAL VANCOMYCIN, CEFTAZIDIME, AND ZOFRAN. ON POD315, IOP WAS 1 MMHG, PROXIMAL SEGMENT OF STENT REMAINS IN ANTERIOR CHAMBER. EVENT NOT RESOLVED.

  Patient problems: Endophthalmitis; Erosion; Loss of Vision

  MAUDE report 24328721 ↗
• MalfunctionFeb 12, 2026Contamination

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "LOOSE FOREIGN MATERIAL (PLASTIC) AT THE TIP OF THE INJECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328441 ↗
• MalfunctionFeb 9, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS, ¿SLIDER DID NOT OPERATE PROPERLY DURING SURGERY IN THE RIGHT SIDE¿. THERE WAS NO INJURY TO THE PATIENT. IT IS NOT KNOWN WHETHER IF BACKUP WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298716 ↗
• MalfunctionFeb 4, 2026Physical Resistance/Sticking

  HEALTHCARE PROFESSIONAL REPORTED A XEN®45 GTS "DID NOT EJECT/DEVICE SLIDER DID NOT WORK." DEVICE DID NOT MAKE PATIENT CONTACT. SURGERY WAS COMPLETED WITH BACKUP DEVICE. NO EYE INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259478 ↗
• InjuryJan 30, 2026Complete Blockage

  HEALTHCARE PROFESSIONAL REPORTED 3 XEN®45 GTS "WITH VERY LITTLE FLOW OR NO FLOW AT ALL" WITHIN 1ST POSTOPERATIVE WEEK.

  Patient problems: Failure of Implant

  MAUDE report 24223420 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161457. One submission often covers many models, so check the product and lot details in each record.

• Z-0598-2020 · Oct 30, 2019 · Open, Classified
  XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatm