CAPIO IPN000859Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14026704603876), received between Jul 22, 2021 and Aug 24, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CAPIO SLIM'S CARRIER GOT STUCK IN THE CAGE WHEN THE SURGEON TRIED TO SUTURE AND TEARS THE POLYESTER THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282469 ↗
• MalfunctionFeb 2, 2022Break; Break

  CAPIO SUTURE BROKE OFF INSIDE PATIENT. POSSIBLE CAPIO HAND PIECE OR SUTURE ERROR. THE DART FROM THE CAPIO SUTURE BROKE OFF. THE DOCTOR SAID IT MALFUNCTIONED AND THE SUTURE DART CAME OFF OR FELL OFF OR WAS CUT OFF AND HE COULD NOT CAPTURE THE SUTURE AND THE DART IS NOW LEFT INSIDE THE PATIENT. CANNOT RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13427623 ↗
• InjuryJan 24, 2022Product Quality Problem; Product Quality Problem

  I WOULD LIKE TO REPORT A NON-CONFORMITY RELATED TO THE CAPIO SUTURE THREAD (B)(4). UPDATE: THE SURGEONS DESCRIBED IN THEIR REPORT, AS FOLLOWS: SINCE THE DISCONTINUATION OF THE SUPPLY OF ABSORBABLE SUTURE THREAD, WHERE WE USED SACROSPINOUS FIXATION FOR COLPUS WE HAVE HAD POSTOPERATIVE COMPLICATIONS DUE TO THE FACT THAT THE THREAD IS NON-ABSORBABLE WE HAVE HAD IMPORTANT GRANULOMAS AT THE SITE, INFECTIOUS PROCESSES AT THE SITE DUE TO THE FOREIGN BODY IN THE VAGINA AND NEED FOR REHOSPITALIZATION UNDERGOING SPINAL ANESTHESIA TO ATTEMPT TO REMOVE THE WIRE, WHICH GENERATES RISK TO THE PATIENT AND COSTS TO THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 13334258 ↗
• MalfunctionOct 14, 2021Break; Break

  CURE OF PROLAPSE ON (B)(6) 2019. WHEN USING CAPIO SUTURES, 2 HARPOONS (ATTACHED TO THE SACROSPINOUS LIGAMENT THROUGH FORCEPS) DISLODGED FROM THE WIRE DURING THE 1ST AND 3RD PASSAGES. PRESENCE OF 2 FREE HARPOONS IN THE SACROSPINOUS LIGAMENT NOT LINKED TO A WIRE: RISK OF MIGRATION THAT CAN HAVE POTENTIALLY SERIOUS CLINICAL CONSEQUENCES FOR THE PATIENT. NEED TO CHANGE THE MEDICAL DEVICE IN ORDER TO CONTINUE THE PROCEDURE. EXTENSION OF THE PROCEDURE LENGTH. DEVICE 3 OF 3. EVENT DATE: (B)(6) 2019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632358 ↗
• MalfunctionAug 24, 2021Break; Break

  DURING SACROSPINOUS FIXATION AFTER TRIGGERING THE CAPIO AND WHEN THE DOCTOR DRAGGED THE SUTURE THE SUTURE TEARED SUDDENLY. OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358729 ↗
• MalfunctionJul 26, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING SACROSPINOUS FIXATION THE BULLET AT THE TIP OF THE SUTURE GOT STUCK IN THE CAPIO SLIM WHILE PUSHING THE HANDLE OF THE CAPIO. THIS EVENT HAPPENED SEVERAL TIMES AND FINALLY, SHE HAD TO USE ANOTHER CAPIO SLIM TO SOLVE THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225498 ↗
• MalfunctionJul 22, 2021Break; Break

  DURING SACROSPINOUS FIXATION AFTER TRIGGERING THE CAPIO AND WHEN THE DOCTOR DRAGGED THE SUTURE THE SUTURE TORE SUDDENLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213577 ↗