Altis 519650Recalls & reported problems

Summary

The FDA's MAUDE database contains 540 adverse event reports that list this exact device (DI 05708932467407), received between Oct 5, 2016 and Jul 7, 2026 — classified as 235 injuries, 305 malfunctions.

The most frequently reported specific device problem is “Break” (213 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 540 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Material Fragmentation

  ACCORDING TO THE AVAILABLE INFORMATION, THE DYNAMIC ANCHOR APPEARS TO HAVE COME APART OR FAILED. THE SLING WAS CUT OUT AND A NEW SLING WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A 30 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25733808 ↗
• MalfunctionJun 29, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A POSSIBLE SUTURE BREAK. ANOTHER DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658279 ↗
• MalfunctionJun 29, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, A POSSIBLE SUTURE BREAK OCCURRED. A NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25656911 ↗
• MalfunctionJun 29, 2026Material Fragmentation

  ACCORDING TO THE AVAILABLE INFORMATION, THE DYNAMIC ANCHOR SEPARATED. THE PRONG OF THE ANCHOR DISLODGED OFF DYNAMIC ANCHOR DURING TENSIONING. IT WAS NOTED NO DIFFICULT PLACEMENT AND NO STRUGGLES AGAINST BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651477 ↗
• MalfunctionJun 29, 2026Material Fragmentation

  ACCORDING TO THE AVAILABLE INFORMATION, THE DYNAMIC ANCHOR SEPARATED. THE PRONG OF ANCHOR DISLODGED OFF DYNAMIC ANCHOR DURING TENSIONING. IT WAS NOTED NO DIFFICULT PLACEMENT AND NO STRUGGLES AGAINST BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651431 ↗
• MalfunctionJun 29, 2026

  ALTIS SLING STRING CAME APART WHEN IMPLANTING IT INTO THE PATIENT. ALL PIECES REMOVED AND NEW SLING OPENED AND PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650024 ↗
• MalfunctionJun 26, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE STATIC ANCHOR BROKE OFF DURING PLACEMENT. A SECOND SLING WAS OPENED, SLING WAS PLACED [SUCCESSFULLY].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635657 ↗
• InjuryJun 25, 2026Device Dislodged or Dislocated

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT HAD AN ALTIS DEVICE IMPLANTED IN (B)(6) 2024 WHICH INITIALLY IMPROVED STRESS URINARY INCONTINENCE. THE PATIENT REPORTEDLY EXPERIENCED VISIBLE AND PALPABLE MESH THROUGH INCISION. THE PHYSICIAN NOTED THE SLING LIKELY DISLODGED DURING HEALING PROCESS FROM A STRONG COUGH. THE PATIENT EXPERIENCED EXPOSURE OF VAGINAL MESH, STRESS INCONTINENCE, URGE INCONTINENCE AND UNDERWENT EXCISION OF ALTIS MIDURETHRAL SLING & CYSTOSCOPY. ADDITIONALLY, INCISION & DRAINAGE OF A POSTERIOR VAGINAL ABSCESS/DEEP PERINEAL ABSCESS UNDER GENERAL ANESTHESIA WAS PERFORMED BUT NOT RELATED TO ALTIS.

  Patient problems: Micturition Urgency; Urinary Incontinence

  MAUDE report 25625661 ↗
• MalfunctionJun 24, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE SLING BROKE WHEN TENSIONING. A NEW SLING WAS USED TO FINISH THE CASE WITH NO ISSUES. A 10-MINUTE DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613272 ↗
• MalfunctionJun 24, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION IN MEDSUN REPORT (B)(4): "THEN, THE TIP OF THE ANCHOR WAS ORIENTED PERPENDICULAR TO THE OBTURATOR INTERNUS MUSCLE. THE TIP OF THE TROCAR WAS INTRODUCED INTO THE OBTURATOR INTERNUS MUSCLE UNTIL A POP WAS FELT, THEN THE INTRODUCER WAS ROTATE 1/4 TURN. THE ANCHOR WAS THEN DEPLOYED IN PLACE. THE SAME PROCEDURE WAS PERFORMED ON THE OTHER SIDE AND THE SLING WAS TENSIONED. HOWEVER, DURING TENSIONING, THE SUTURE BROKE OFF THE TENSIONER AND THE SLING HAD TO BE REMOVED, BUT THE ANCHORS WERE LEFT IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612985 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD AN ALTIS IMPLANTED ON (B)(6) 2025. REPORTEDLY, THE PATIENT EXPERIENCED FEELING WIRE AND SOMETHING SHARP IN HER VAGINA AND VAGINAL IRRITATION, MESH EROSION ON THE LEFT SIDE, PAIN AT HER LOWER ABDOMEN, PELVIC AREA, LOWER BACK, AND SOMETIMES WITH VOIDING. EXCISION OF ALTIS UNDER GENERAL ANESTHESIA WAS PERFORMED ON (B)(6) 2026. PATHOLOGY DESCRIPTION: MESH MEASURING 1.2 X 1.2 CM, ROUGHLY SQUARE. REPORTEDLY, THE CLAIMANT REPORTS CONTINUED VAGINAL DISCHARGE, ODOR, AND PAIN FROM SURGERY.

  Patient problems: Abnormal Vaginal Discharge; Dysuria; Erosion; Inflammation; Pain; Pelvic Pain

  MAUDE report 25611925 ↗
• MalfunctionJun 23, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE ALTIS DYNAMIC SIDE BROKE DURING PREPARATION (DYNAMIC ¿ SUTURE TO MESH BREAK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600595 ↗
• MalfunctionJun 23, 2026Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, THE TIP OF THE TROCAR BROKE AND THE DYNAMIC ANCHOR WAS TORN FROM SUTURE. THE SURGEON SEEMED TO HAVE A HARD TIME GETTING THE DYNAMIC ANCHOR TO PLACE INTO OBTURATOR MEMBRANE. USED ANOTHER ALTIS SLING AND EVERYTHING PROGRESSED AS EXPECTED. THIS REPORT CAPTURES THE TROCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593897 ↗
• MalfunctionJun 23, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE TIP OF THE TROCAR BROKE AND THE DYNAMIC ANCHOR WAS TORN FROM SUTURE. THE SURGEON SEEMED TO HAVE A HARD TIME GETTING THE DYNAMIC ANCHOR TO PLACE INTO OBTURATOR MEMBRANE. USED ANOTHER ALTIS SLING AND EVERYTHING PROGRESSED AS EXPECTED. THIS REPORT CAPTURES THE ANCHOR TO SUTURE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593776 ↗
• MalfunctionJun 22, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE SURGEON BELIEVED THAT THEY HAD ANCHORED THE STATIC SIDE UNEVENTFULLY BUT UPON REMOVING THE TROCAR AND CHECKING ANCHOR PLACEMENT, IT WAS OBSERVED THAT THE ANCHOR HAD DETACHED FROM THE STATIC SUTURE [STATIC - SUTURE TO MESH BREAK]. THE ANCHOR WAS LEFT IN PLACE, AND THE SURGEON IMPLANTED A NON-COLOPLAST DEVICE UNEVENTFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25581947 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: ON OR ABOUT (B)(6), 2020, PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT HER STRESS URINARY INCONTINENCE AND VAGINAL PROLAPSE, DURING WHICH HER PHYSICIAN IMPLANTED THE COLOPLAST ALTIS MINI SINGLE INCISION SLING MESH AND COLOPLAST RESTORELLEY-MESH INTO THE PATIENT. PATIENT SUBSEQUENTLY SUFFERED COMPLICATIONS ASSOCIATED WITH THE PELVIC MESH PRODUCTS, INCLUDING BUT NOT LIMITED TO, PELVIC PAIN, PROTRUSION, EXTRUSION, EROSION, URINARY ISSUES, URINARY INCONTINENCE, RECURRENCE, BLEEDING, DYSPAREUNIA, HEAVY DISCHARGE, VAGINAL SCARRING, INFECTIONS, PERMANENT DISFIGUREMENT, EXPOSURE OF THE MESH TO SURROUNDING TISSUE/ORGANS, AND DIFFICULTY WITH DAILY ACTIVITIES. ON OR AROUND (B)(6), 2024, PATIENT UNDERWENT VAGINAL MESH EXCISION. ON OR AROUND (B)(6), 2025, PATIENT UNDERWENT VAGINAL MESH REMOVAL SURGERY. PATIENT HAS SUFFERED, AND CONTINUES TO SUFFER, MULTIPLE, SEVERE, AND PAINFUL PERSONAL INJURIES, INCLUDING, BUT NOT LIMITED TO, EROSION, BLEEDING, PROTRUSION, EXTRUSION, VAGINAL AND PELVIC PAIN, DYSPAREUNIA, URINARY URGENCY AND INCONTINENCE ISSUES, SCARRING, PERMANENT PHYSICAL DEFORMITY, AND DIFFICULTY WITH DAILY ACTIVITIES, WHICH SHE WILL CONTINUE

  Patient problems: Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Pain; Pelvic Pain; Scar Tissue; Unspecified Infection; Urinary Incontinence

  MAUDE report 25458941 ↗
• MalfunctionJun 9, 2026Material Fragmentation

  ACCORDING TO THE AVAILABLE INFORMATION, A DYNAMIC ANCHOR SEPARATION OCCURRED DURING IMPLANT OF AN ALTIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447005 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT HAD AN ALTIS DEVICE IMPLANTED AND EXPERIENCED THE FOLLOWING: PELVIC PRESSURE, CONSTIPATION, SHORTNESS OF BREATH WITH EXERTION, BURNING AND MUSCLE TWITCHING AT INCISION SITES, SMALL AMOUNT OF GRANULATION TISSUE IN RIGHT CORNER OF VAGINAL CUFF, VAGINAL ODOR, VAGINAL PAIN, ABDOMINAL PAIN AND CRAMPING, EROSION AND EXPOSURE, TENDERNESS ON PALPATION, PAIN WITH SITTING, DYSPAREUNIA, DYSURIA, ACHING IN LEGS AND HIPS, URINARY FREQUENCY AND NOCTURIA. IN (B)(6) 2025, PATIENT UNDERWENT VAGINAL MESH EXCISION AND CYSTOURETHROSCOPY UNDER GENERAL ANESTHESIA. 1 CM SLING EROSION ALONG THE LEFT PARAVAGINAL SULCUS AT THE 3 O¿CLOCK POSITION WAS EXCISED. REPORTEDLY THE PATIENT EXPERIENCED MUSCLE TIGHTNESS IN PELVIS, DYSPAREUNIA, FURTHER MESH EXPOSURE JUST DISTAL TO URETHRAL MEATUS, WHICH WAS PAINFUL ON PALPATION, POKING SENSATION, VAGINAL BURNING, PAIN WITH SITTING, STRESS URINARY INCONTINENCE AND BEING SEXUALLY INACTIVE DUE TO PAIN. IN (B)(6) 2026, PATIENT UNDERWENT REMOVAL OF SYNTHETIC STRESS INCONTINENCE SLING, CYSTOURETHROSCOPY EXAM UNDER ANESTHESIA AND PERIURETHRAL INJECTION OF BULKAMID. PATIENT HAD ACUTE URINARY RETENTION POST-OP.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Cramp(s) /Muscle Spasm(s); Dyspareunia; Dysuria; Erosion; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 25446888 ↗
• MalfunctionMay 11, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE ANCHOR ON THE STATIC SIDE PULLED AWAY FROM THE MESH AFTER SUCCESSFUL IMPLANTATION WHEN NORMAL PRESSURE WAS APPLIED TO LOAD THE OTHER SIDE. A NEW ALTIS SLING WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136720 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN REPORTS THAT PATIENT'S COMPLAINT ABOUT PAIN WITH VAGINAL PENETRATION AFTER IMPLANTED WITH COLOPLAST SLINGS.

  Patient problems: Dyspareunia

  MAUDE report 25124932 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN REPORTS THAT PATIENT'S COMPLAIN ABOUT PAIN WITH VAGINAL PENETRATION AFTER IMPLANTED WITH COLOPLAST SLINGS.

  Patient problems: Dyspareunia

  MAUDE report 25124780 ↗
• MalfunctionMay 8, 2026Difficult or Delayed Positioning; Material Too Rigid or Stiff; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN REPORTED THAT THE ALTIS SLINGS ARE MUCH STIFFER MAKING PLACEMENT AND TENSIONING MORE DIFFICULT THAN THE BOSTON SCIENTIFIC PRODUCTS. THE ALTIS SLING FOLDS ON ITSELF WAY TOO EASILY AND WHEN SHE IS OPERATING IN A TINY 1 INCH SPACE THAT IS BLEEDING, SHE SPENDS WAY TOO MUCH TIME TRYING TO SEE AND ADJUST IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124613 ↗
• InjuryMay 8, 2026Device Slipped

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN HAD TO TAKE SEVERAL PATIENTS BACK FOR REVISIONS BECAUSE THE TENSIONING ON THE ALTIS WASN¿T CORRECT.

  Patient problems: Insufficient Information

  MAUDE report 25124529 ↗
• InjuryMay 8, 2026Device Slipped

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN HAD TO TAKE SEVERAL PATIENTS BACK FOR REVISIONS BECAUSE THE TENSIONING ON THE ALTIS WASN¿T CORRECT.

  Patient problems: Insufficient Information

  MAUDE report 25123066 ↗
• MalfunctionMay 5, 2026Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, A MESH TEAR ON THE STATIC SIDE OCCURRED WHILE POSITIONING THE STATIC ANCHOR. ANOTHER SLING WAS IMPLANTED AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086631 ↗