CAPIO IPN000861Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14026704603890), received between Apr 19, 2021 and Dec 12, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2022Separation Problem; Separation Problem

  REPORTED ISSUE: NEEDLE BREAKAGE DURING A SUTURE WITH CAPIO BRAND 0 BLUE MONOFILAMENT POLYPROPYLENE THREADS. A NEW THREAD WAS THEN USED, AND IT GOT DISLODGED. THE INCIDENT TOOK PLACE ON (B)(4), IN THE OR, CAUSING A SUTURE TO BE UNDONE, TO BE RESUMED AND THUS TO EXTEND THE INTERVENTION TIME. NO CLINICAL SIGNS OR SYMPTOMS; CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958880 ↗
• MalfunctionDec 12, 2022Material Separation; Material Separation

  REPORTED ISSUE: NEEDLE BREAKAGE DURING A SUTURE WITH CAPIO BRAND 0 BLUE MONOFILAMENT POLYPROPYLENE THREADS. A NEW THREAD WAS THEN USED, AND IT GOT DISLODGED. THE INCIDENT TOOK PLACE ON (B)(6) 2022, IN THE OR, CAUSING A SUTURE TO BE UNDONE, TO BE RESUMED AND THUS TO EXTEND THE INTERVENTION TIME. NO CLINICAL SIGNS OR SYMPTOMS; CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958831 ↗
• MalfunctionSep 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE DART DETACHED. THERE WERE NO CLINICAL SIGNS OR SYMPTOMS OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508432 ↗
• MalfunctionFeb 23, 2022Break; Break

  ON (B)(6) 2022, IN THE GYNECOLOGICAL OPERATING ROOM, USE OF A CAPIO POLYPROPYLENE SUTURE AS PART OF AN ORGAN DESCENT. WHEN PASSING THROUGH THE LIGAMENT TO SUSPEND THE ORGANS, THE SUTURE BROKE. THE DART OF THE DEVICE REMAINED IN THE LIGAMENT. USE OF ANOTHER DEVICE OF THE SAME REFERENCE TO REMEDY THE INCIDENT. REPETITIVE INCIDENT. TO THIS DAY THERE IS STILL A FOREIGN BODY INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587016 ↗
• MalfunctionJan 6, 2022Break; Break

  ON (B)(6) 2021, IN THE GYNECOLOGICAL UNIT, A CAPIO POLYPROPYLENE THREAD WAS USED WITH CAPIO SLIM FOR TREATMENT OF PROLAPSE. DURING THE SECOND PASSAGE THROUGH THE LIGAMENT TO SUSPEND THE ORGANS, THE THREAD BROKE. THE DART OF THE DEVICE HAS REMAINED IN THE LIGAMENT. USE OF ANOTHER DEVICE WITH THE SAME REFERENCE TO PALLIATE THE INCIDENT. NO CONSEQUENCE FOR THE PATIENT. ISOLATED INCIDENT. TO THIS DAY THE FOREIGN BODY IS STILL IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176877 ↗
• MalfunctionJun 23, 2021Break; Break

  SUTURE WAS BEING RETRACTED FROM PATIENT TO RE-THROW AND BULLET WAS MISSING UPON EXTRACTION. ADDITIONAL INFORMATION: THE DETACHED DART (BULLET) REMAINED INSIDE THE PATIENT AND COULD NOT BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049333 ↗
• MalfunctionApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  SUTURE WAS BEING RETRACTED FROM PATIENT TO RE-THROW AND BULLET WAS MISSING UPON EXTRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685790 ↗