MONODEK IPN000864Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 14026704603920), received between Aug 24, 2021 and Apr 20, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE SURGEON REPORTED THAT THE SUTURES TORE COMPLETELY DURING USE WITH THE CAPIO SLIM DEVICE. MULTIPLE SUTURES WERE USED, AND THREE SUTURES FROM THE SAME LOT NUMBER WERE REPORTED TO HAVE TORN. THE TEAM HAS SEGREGATED THIS LOT FROM THE REMAINING STOCK AS A PRECAUTION AND HAVE RAISED CONCERNS THAT THIS MAY BE A FAULTY BATCH". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931650 ↗
• MalfunctionApr 20, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE SURGEON REPORTED THAT THE SUTURES TORE COMPLETELY DURING USE WITH THE CAPIO SLIM DEVICE. MULTIPLE SUTURES WERE USED, AND THREE SUTURES FROM THE SAME LOT NUMBER WERE REPORTED TO HAVE TORN. THE TEAM HAS SEGREGATED THIS LOT FROM THE REMAINING STOCK AS A PRECAUTION AND HAVE RAISED CONCERNS THAT THIS MAY BE A FAULTY BATCH". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931560 ↗
• MalfunctionApr 20, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE SURGEON REPORTED THAT THE SUTURES TORE COMPLETELY DURING USE WITH THE CAPIO SLIM DEVICE. MULTIPLE SUTURES WERE USED, AND THREE SUTURES FROM THE SAME LOT NUMBER WERE REPORTED TO HAVE TORN. THE TEAM HAS SEGREGATED THIS LOT FROM THE REMAINING STOCK AS A PRECAUTION AND HAVE RAISED CONCERNS THAT THIS MAY BE A FAULTY BATCH". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931501 ↗
• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED "THE SUTURE IS LOADED INTO THE CAPIO SLIM, THERE ARE TWO ENDS TO THE SUTURE ONE HOLDS A NEEDLE THE OTHER LOOKS LIKE A ANCHOR, THIS IS APPROX 2MM X .5MM. FOLLOWING REMOVAL OF THE DEVICE THE 'ANCHOR' WAS NOT FOUND AND MUST HAVE BECOME DISLODGED DURING USE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558806 ↗
• MalfunctionJan 2, 2026Mechanical Jam

  IT WAS REPORTED THAT "DUE TO SEVERAL FAULTY CAPIO SLIM SUTURING DEVICES, THE PHYSICIAN HAD TO WASTE 2 MONODEK SUTURES. ONE OF THE SUTURES HAD ITS BULLET STUCK IN THE HEAD OF THE CAPIO SLIM DEVICE WHEN IT WAS TRYING TO BE FIRED INTO THE LIGAMENT. PHYSICIAN HAD TO USE 4 MONODEK AND 2 WERE LEFT IN THE PATIENT'S SACROSPINOUS LIGAMENT. THE PATIENT DID FINE. PATIENT WAS NOT AFFECTED BY THE INCONVENIENCE." ASSOCIATED MDRS: 3004365956-2025-00066 AND 3004365956-2026-00001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950572 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT "FIRST, A POLYPROPYLENE 36IN SUTURE WAS USED - IT BROKE DOWN TO PIECES (INSIDE THE PATIENT) AFTER TIGHTENING. THE PHYSICIAN THEN DECIDED TO USE MONODEK SUTURE INSTEAD TO FINISH THE PROCEDURE. WHILE UNPACKING THE MONODEK AND CATCHING IT WITH A "MOSQUITO", IT BROKE FROM NEEDLE SEPARATED FROM THE SUTURE AND THE SUTURE BROKE DOWN TO SMALL PIECES WITH EVERY TOUCH. THIS HAPPENED 3 TIMES WHILE UNPACKING MONODEK SUTURES OF THE SAME BOX. THE 4TH MONODEK SUTURE THAT WAS OPENED WAS OK AND GOOD FOR USE, SO THE DOCTOR FINISHED THE PROCEDURE AND PATIENT WAS RELEASED AFTER A NIGHT OF HOSPITALIZATION FOR OBSERVATION". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS 3004365956-2025-00068, 3004365956-2025-00069, 3004365956-2025-00070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896690 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT "FIRST, A POLYPROPYLENE 36IN SUTURE WAS USED - IT BROKE DOWN TO PIECES (INSIDE THE PATIENT) AFTER TIGHTENING. THE PHYSICIAN THEN DECIDED TO USE MONODEK SUTURE INSTEAD TO FINISH THE PROCEDURE. WHILE UNPACKING THE MONODEK AND CATCHING IT WITH A "MOSQUITO", IT BROKE FROM NEEDLE SEPARATED FROM THE SUTURE AND THE SUTURE BROKE DOWN TO SMALL PIECES WITH EVERY TOUCH. THIS HAPPENED 3 TIMES WHILE UNPACKING MONODEK SUTURES OF THE SAME BOX. THE 4TH MONODEK SUTURE THAT WAS OPENED WAS OK AND GOOD FOR USE, SO THE DOCTOR FINISHED THE PROCEDURE AND PATIENT WAS RELEASED AFTER A NIGHT OF HOSPITALIZATION FOR OBSERVATION". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS 3004365956-2025-00068, 3004365956-2025-00069, 3004365956-2025-00071.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896628 ↗
• MalfunctionDec 26, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT "FIRST, A POLYPROPYLENE 36IN SUTURE WAS USED - IT BROKE DOWN TO PIECES (INSIDE THE PATIENT) AFTER TIGHTENING. THE PHYSICIAN THEN DECIDED TO USE MONODEK SUTURE INSTEAD TO FINISH THE PROCEDURE. WHILE UNPACKING THE MONODEK AND CATCHING IT WITH A "MOSQUITO", IT BROKE FROM NEEDLE SEPARATED FROM THE SUTURE AND THE SUTURE BROKE DOWN TO SMALL PIECES WITH EVERY TOUCH. THIS HAPPENED 3 TIMES WHILE UNPACKING MONODEK SUTURES OF THE SAME BOX. THE 4TH MONODEK SUTURE THAT WAS OPENED WAS OK AND GOOD FOR USE, SO THE DOCTOR FINISHED THE PROCEDURE AND PATIENT WAS RELEASED AFTER A NIGHT OF HOSPITALIZATION FOR OBSERVATION". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS 3004365956-2025-00068, 3004365956-2025-00070, 3004365956-2025-00071.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896605 ↗
• MalfunctionDec 23, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "DUE TO SEVERAL FAULTY CAPIO SLIM SUTURING DEVICES, THE PHYSICIAN HAD TO WASTE 2 MONODEK SUTURES. ONE OF THE SUTURES HAD ITS BULLET STUCK IN THE HEAD OF THE CAPIO SLIM DEVICE WHEN IT WAS TRYING TO BE FIRED INTO THE LIGAMENT. PHYSICIAN HAD TO USE 4 MONODEK AND 2 WERE LEFT IN THE PATIENT'S SACROSPINOUS LIGAMENT. THE PATIENT DID FINE. PATIENT WAS NOT AFFECTED BY THE INCONVENIENCE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878062 ↗
• MalfunctionJan 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "CAPIO MONODEK BULLET BROKE OFF MIDWAY DURING PROCEDURE. BULLET NOW MISSING AND SURGEON AND TEAM CAN'T FIND THE BULLET. TEAM FOLLOWED MISSING INSTRUMENT PROTOCOL. RUBBISH BAGS SEARCHED, MAGNETIC ROLLER USED AND X-RAY WAS USED FOR FINAL CONFIRMATION THAT THE BULLET IS NOT LEFT INSIDE THE PATIENT. SURGEON CONFIRMED WITH X-RAY THAT THE MISSING BULLET IS NOT INSIDE THE PATIENT". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103042 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "[USER] CALLED ME AND SAID THAT THE CAPIO DEVICE DEPLOYED AND WHEN [DOCTOR] PULLED BACK THE PULLED HAD SHEARED OFF FROM THE SUTURE. IT CAME OFF IN THE PATIENT. THEY DID AN XRAY TO SEE IF THEY COULD SEE WHERE THE BULLET WENT, AND THEY COULD NOT SEE IT IN THE PATIENT. THE PHYSICIAN DECIDED TO LEAVE IT AND OPEN ANOTHER SUTURE TO COMPLETE THE CASE. HE TRIED ANOTHER OF THE SAME TYPE OF SUTURE AND THEN OPENED A SECOND CAPIO DEVICE. NO PATIENT COMPLICATIONS".

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451882 ↗
• InjuryNov 21, 2023Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT "USING A CAPIO SLIM DEVICE AND MONODEK SUTURE, WHILE THE CAPIO DEVICE WAS ACTIVATED INSIDE THE PATIENT TO SHOOT THE BULLET THROUGH THE LIGAMENT, THE BULLET BECAME COMPLETELY UNATTACHED FROM THE SUTURE - THE SUTURE CAME OUT AND THE BULLET WAS LOST INSIDE THE PATIENT. WE HAD TO GET XR IN AND SURE ENOUGH IT WAS LOCATED WITHIN THE PELVIS AND HAS HAD TO BE LEFT IN SITU DECISION MADE BY GYNAE CONSULTANT USING THE DEVICE AND ALSO ON CALL GENERAL SURGEON ADVICE. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18182114 ↗
• MalfunctionJul 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE DOCTOR WENT TO LOAD THE NEEDLE, THE "BULLET" FLEW OFF, THEN UPON TRYING A NEW NEEDLE, IT WOULD NOT WORK AT ALL. NO PATIENT HARM OR INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252398 ↗
• MalfunctionDec 7, 2022Material Separation; Material Separation

  REPORTED ISSUE: DURING A SACROSPINOUS LIGAMENT FIXATION, THE DOCTOR TRIED TO FIRE THE CAPIO AND THE SUTURE BULLET BROKE OFF AND FELL ON THE GROUND. THEN THE CAPIO WAS NOT ABLE TO FIRE, DESPITE THE SURGEON IRRIGATING THE DEVICE. THEY OPENED A NEW CAPIO DEVICE AND IT DEPLOYED THE FIRST TIME. THE BREAK WAS RIGHT AT THE DART ON THE PDS SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933230 ↗
• MalfunctionOct 17, 2022Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE OFF DURING COLPOPEXY PROCEDURE, LEAVING BEHIND A SMALL BULLET END TO THE SUTURE INSIDE THE PATIENT'S VAGINAL CANAL DURING A GYNECOLOGY PROCEDURE. SUTURE IS A MONODEK O ABSORBABLE SUTURE MADE BY TELEFLEX. THE DOCTOR SUTURED THE OPERATIVE SITE CLOSED. X-RAY WAS TAKEN PER POLICY POST PROCEDURE. THE BULLET WAS NOT DETECTABLE IN THE X-RAY. THE PATIENT'S CONDITION AND THE EVENT DATE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15619661 ↗
• MalfunctionOct 17, 2022Material Separation; Material Separation

  DURING A CASE WHERE HE WAS USING THE CAPIO AND MONODEK SUTURE, THE DOCTOR HAD ISSUES FIRING THE CAPIO THROUGH THE SACROSPINOUS LIGAMENT. HE TRIED TO DEPLOY THE CAPIO TO TREAD THE MONODEK SUTURE, BUT IT COULD NOT PENETRATE THE LIGAMENT IN FULL. IN TOTAL, THE DOCTOR HAD TO USE 3 CAPIOS AND 10 MONODEK TO GET A SUCCESSFUL DEPLOYMENT. THE DOCTOR HAS BEEN USING THE CAPIO FOR AROUND 15 YEARS AND HAD NO ISSUES. HE HAS USED CAPIO SINCE AND HAD NO ISSUES. DURING THE PROCEDURE, THE DOCTOR SAID THAT THE METAL TIP ON THE END OF THE MONODEK SEPARATED FROM THE SUTURE WHILST INSIDE THE LIGAMENT. HE WAS UNABLE TO RETRIEVE THE MONODEK POINT AND IT REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615254 ↗
• MalfunctionSep 27, 2022Material Separation; Material Separation

  PHYSICIAN SAYS THAT WHEN HE FIRED THE SUTURE TO DEPLOY THROUGH THE LIGAMENT, THE BULLET ON THE END OF THE SUTURE GETS STUCK. HE ATTEMPTED A SECOND TIME AND THE DEVICE MISFIRED. LAST ATTEMPT THE BULLET CAME OFF SUTURE. PHYSICIAN OPENED A NEW CAPIO SLIM AND COMPLETED THE PROCEDURE WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494966 ↗
• MalfunctionAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN SAYS THAT WHEN HE FIRES THE SUTURE TO DEPLOY THROUGH THE LIGAMENT, THE BULLET ON THE END OF THE SUTURE GETS STUCK. HE ATTEMPTED A SECOND TIME AND THE DEVICE MISFIRED. LAST ATTEMPT THE BULLET CAME OFF SUTURE. PHYSICIAN OPENED A NEW CAPIO SLIM AND COMPLETED THE PROCEDURE WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321801 ↗
• MalfunctionJun 14, 2022Break; Break

  MEDWATCH REPORT# (B)(4). DART PORTION AT THE END OF SUTURE BROKE OFF AND RESULTED IN A RETAINED FOREIGN BODY. DISCLOSED TO FAMILY AND PATIENT AND DECISION TO LEAVE IN PLACE WAS MADE. ANOTHER SIMILAR INCIDENT OCCURRED BUT THE DART WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685379 ↗
• MalfunctionAug 24, 2021Break; Break

  DART DETACHED FROM CAPIO SUTURE AND DART POTENTIALLY BROKE AS WELL. OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359598 ↗