TELEFLEX IPN056767Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 14026704735324), received between Feb 13, 2023 and Mar 26, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT "CUSTOMER CALLED ME TO LET ME KNOW A CAPIO SUTURE BULLET WAS RETAINED IN THE PATIENT." NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707499 ↗
• 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 3004365956-2025-00069, 3004365956-2025-00070, 3004365956-2025-00071.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896586 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "THE BULLET (DART) FROM SUTURE SNAPPED OFF IN PATIENT, REOPENED AS SEEN UNDER X-RAY BUT UNABLE TO REMOVE IT WHERE ITS LOCATED ITS INACCESSIBLE". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645318 ↗
• MalfunctionMay 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING VAGINAL CYSTOCELE REPAIR, THE CAPIO SYSTEM WAS USED TO PASS A WIRE THROUGH THE SACROSPINOUS LIGAMENT. ON THE RIGHT, TWO WIRES WERE INSERTED NORMALLY. ON THE LEFT, DURING THE PASSAGE OF THE FIRST WIRE, THE STITCH AT THE END OF THE WIRE DISLODGED AND GOT STUCK IN THE LIGAMENT (THE WIRE RETURNED WITHOUT THE STITCH). THE STITCH COULD NOT BE RETRIEVED OR LOCATED AND WAS LEFT IN PLACE. NO TECHNICAL DIFFICULTIES WERE ENCOUNTERED DURING THE PROCEDURE, AND THE WIRE AND THE CAPIO WERE HANDLED WITH CARE. CLINICAL CONSEQUENCES AND CURRENT STATE OF THE PATIENT OR PERSON INVOLVED: NO APPARENT CONSEQUENCES FOR THE PATIENT."

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

  MAUDE report 21975067 ↗
• MalfunctionMar 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "[PHYSICIAN] DEPLOYED A CAPIO WHILE DOING A SACROSPINOUS FIXATION AND THE BULLET WAS LEFT BEHIND IN THE SAC LIG AMENT". ADDITIONAL INFORMATION RECEIVED STATES THAT IT IS UNKNOWN WHETHER THE DEVICE WAS REMOVED FROM THE PATIENT. THE CURRENT PATIENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 21573174 ↗
• MalfunctionNov 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING SURGERY FOR TREATMENT OF VAGINAL CYSTOCELE, USE OF THE CAPIO BOSTON PASS-THREAD SYSTEM WITH ADAPTED THREADS. WHEN LIGATING WITH THE SECOND SUTURE, THE SUTURE ANCHOR REMAINED IN THE LIGAMENT BECAUSE THE SUTURE LOOSENED WHEN THE DEVICE WAS RETRIEVED. THERE WAS NO ABNORMAL TENSION OR FORCE APPLIED. THE THREAD AND DEVICE WERE EASILY REMOVED, BUT THE ANCHOR WAS NOT AMONG THEM. CHECK WITH INTRAOPERATIVE IMAGE INTENSIFIER: ANCHOR IN THE SACROSPINOUS LIGAMENT. NOT PALPABLE, NOT VISIBLE DURING EXPOSURE WITH VALVES. THE EXPERIENCED SURGEON ADVISED TO LEAVE THE ANCHOR IN PLACE. THE SURGERY WAS PROLONGED BY 1 HOUR. POST OPERATION WITHOUT ANY COMPLICATION ON DAY 2. REGULAR POST-SURGERY FOLLOW-UP".

  Patient problems: Foreign Body In Patient

  MAUDE report 20723815 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "DURING PROCEDURE USING A CAPIO DEVICE AND SUTURE, THE BULLET BROKE OFF IN THE PATIENT. DR TRIED TO FIND THE MISSING BULLET FOR A LONG TIME. CLOSED THE PATIENT AND LET THE BULLET INSIDE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348105 ↗
• MalfunctionMar 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "DEVICE WAS CUTTING THE SUTURE BEHIND THE BULLET. CAPIO DEVICE WAS TAKEN APART TO SEE IF BULLET WAS STILL LODGED IN DEVICE, UNABLE TO SEE BULLET". NO REPORT OF PATENT HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18980908 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "CAPIO WENT INTO SSL THE BULLET STAYED IN THE LIGAMENT AND CAME OFF THE SUTURE. THE BULLET COULD NOT BE PALPATED BECAUSE IT WAS DEEP IN THE LIGAMENT. LOCATION WAS CONFIRMED BY INTRAOPERATIVE X-RAY. ". NO PATIENT HARM OR HEALTH CONSEQUENCES. THE CURRENT STATUS OF THE PATIENT IS REPORTED AS "NO HEALTH CONSEQUENCES".

  Patient problems: Insufficient Information

  MAUDE report 18935640 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "ON (B)(6) 2024, IN THE GYNECOLOGY UNIT, DURING A SACRO-SPINO FIXATION, THERE WERE SIGNIFICANT FRICTION FORCES IN THE DEVICE WHICH MADE IT IMPOSSIBLE TO FIX THE SUTURE IN THE FEMALE PATIENT'S TISSUE. THE ISSUE PERSISTED DESPITE THE USE OF SEVERAL WIRES UNTIL THE NEEDLE MISMATCHED AND GOT STUCK IN THE TISSUE. THE DELIVERY DEVICE WAS REPLACED, AND A NEW WIRE WAS USED TO PERFORM THE PROCEDURE. THE PATIENT CONSEQUENCES CONSISTED OF THE PERSISTENCE OF FOREIGN MATERIAL IN THE BODY: THE NEEDLE WAS LEFT IN THE TISSUES, AND THERE WAS ALSO AN EXTENSION OF THE OPERATING TIME". PER THE CUSTOMER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18669768 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "ON (B)(6) 2024, IN THE GYNECOLOGY UNIT, DURING A SACRO-SPINO FIXATION, THERE WERE SIGNIFICANT FRICTION FORCES IN THE DEVICE WHICH MADE IT IMPOSSIBLE TO FIX THE SUTURE IN THE FEMALE PATIENT'S TISSUE. THE ISSUE PERSISTED DESPITE THE USE OF SEVERAL WIRES UNTIL THE NEEDLE MISMATCHED AND GOT STUCK IN THE TISSUE. THE DELIVERY DEVICE WAS REPLACED, AND A NEW WIRE WAS USED TO PERFORM THE PROCEDURE. THE PATIENT CONSEQUENCES CONSISTED OF THE PERSISTENCE OF FOREIGN MATERIAL IN THE BODY: THE NEEDLE WAS LEFT IN THE TISSUES, AND THERE WAS ALSO AN EXTENSION OF THE OPERATING TIME". PER THE CUSTOMER, THERE IS NO ADDITIONAL INFORMATION REGARDING THE STATUS OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18669763 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "THE THREAD WAS CUT SO THAT THE ANCHOR OF THE SUTURE REMAINED IN THE PATIENT. THE PHYSICIAN WAS CAREFUL TO SECURE THE ANCHOR IN THE INSTRUMENT BEFORE BRINGING IT INTO THE PATIENT". FURTHER INFORMATION RECEIVED STATES THAT "THE SUTURE BROKE DURING THE PROCEDURE. THE SURGEON DISASSEMBLED THE INSTRUMENT/REMOVED THE METAL PART TO LOOK FOR THE TOP BUT NO PART REMAINED IN THE PATIENT'S BODY". NO MEDICAL INTERVENTION NECESSARY. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464597 ↗
• MalfunctionNov 27, 2023Disconnection; Material Separation; Disconnection; Material Separation

  IT WAS REPORTED THAT "DURING SUTURE PLACEMENT, THE DART DETACHED FROM THE SUTURE AND REMAINED IN THE LIGAMENT. IT IS SUSPECTED THAT THE DART DID NOT INSERT PROPERLY INTO THE CARRIER AND WAS THEREFORE CUT OFF DURING PLACEMENT. COMPLETED THE PROCEDURE WITH ANOTHER CAPIO SLIM, THE DART REMAINS IN THE LIGAMENT SINCE IT IS TOO SMALL TO GET IT OUT. OVER TIME THE DART WILL BE ENCAPSULATED BY THE BODY. SURGEON TRIED TO REMOVE THE DART BUT WITH NO SUCCESS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "EXPECTED TO FULLY RECOVER".

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

  MAUDE report 18212510 ↗
• MalfunctionOct 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE SUTURE BROKE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDRS #3004365956-2023-00068 AND 3004365956-2023-00070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012034 ↗
• MalfunctionOct 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE SUTURE BROKE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDRS #3004365956-2023-00068 AND 3004365956-2023-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012001 ↗
• MalfunctionOct 24, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE SUTURE BROKE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997934 ↗
• MalfunctionAug 31, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT "UPON PLACING THE CAPIO SLIM INTO THE PATIENT , THE DEVICE HAD MISFIRED AND THE SUTURE DART WAS DEPLOYED AND DISLODGED INTO THE PATIENT. DR HAD RETRACTED THE CAPIO AND COULD NOT FEEL THE DART ANYWHERE WITHIN REACH. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT". ADDITIONAL INFORMATION STATES THAT THE SUTURE BROKE WITHIN THE PATIENT. "FINGERS AND FLUOROSCOPY" WERE USED TO RETRIEVE THE DEVICE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "NO PATIENT COMPLICATIONS".

  Patient problems: Insufficient Information

  MAUDE report 17661599 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT "THE DOCTOR WAS PERFORMING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, IN WHICH A SUTURE IS PLACED THROUGH THAT LIGAMENT. THE DOCTOR REPORTED THAT ONCE HE APPLIED TENSION TO THE SUTURE, THE SUTURE BROKE IN HALF. THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY HOWEVER, HE HAD TO GO THROUGH 2-3 MORE ADDITIONAL SUTURES BREAKING BEFORE GETTING ONES THAT HELD UP. HE DESCRIBED THE CHARACTERISTIC/PERFORMANCE OF THE FAILED SUTURES AS BRITTLE. A NEW SUTURE OF THE SAME TYPE WAS USED". NO PATIENT HARM OR INJURY. NO PART OF THE BROKEN SUTURE REMAINED IN THE PATIENT. SEE ASSOCIATED MDRS #3004365956-2023-00045, 3004365956-2023-00046, 3004365956-2023-00043.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261783 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "THE DOCTOR WAS PERFORMING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, IN WHICH A SUTURE IS PLACED THROUGH THAT LIGAMENT. THE DOCTOR REPORTED THAT ONCE HE APPLIED TENSION TO THE SUTURE, THE SUTURE BROKE IN HALF. THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY HOWEVER, HE HAD TO GO THROUGH 2-3 MORE ADDITIONAL SUTURES BREAKING BEFORE GETTING ONES THAT HELD UP. HE DESCRIBED THE CHARACTERISTIC/PERFORMANCE OF THE FAILED SUTURES AS BRITTLE. A NEW SUTURE OF THE SAME TYPE WAS USED". NO PATIENT HARM OR INJURY. NO PART OF THE BROKEN SUTURE REMAINED IN THE PATIENT. SEE ASSOCIATED MDRS #3004365956-2023-00044, 3004365956-2023-00046, 3004365956-2023-00045.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261704 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT "THE DOCTOR WAS PERFORMING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, IN WHICH A SUTURE IS PLACED THROUGH THAT LIGAMENT. THE DOCTOR REPORTED THAT ONCE HE APPLIED TENSION TO THE SUTURE, THE SUTURE BROKE IN HALF. THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY HOWEVER, HE HAD TO GO THROUGH 2-3 MORE ADDITIONAL SUTURES BREAKING BEFORE GETTING ONES THAT HELD UP. HE DESCRIBED THE CHARACTERISTIC/PERFORMANCE OF THE FAILED SUTURES AS BRITTLE. A NEW SUTURE OF THE SAME TYPE WAS USED". NO PATIENT HARM OR INJURY. NO PART OF THE BROKEN SUTURE REMAINED IN THE PATIENT. SEE ASSOCIATED MDRS #3004365956-2023-00045, 3004365956-2023-00044, 3004365956-2023-00043.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259922 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT "THE DOCTOR WAS PERFORMING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, IN WHICH A SUTURE IS PLACED THROUGH THAT LIGAMENT. THE DOCTOR REPORTED THAT ONCE HE APPLIED TENSION TO THE SUTURE, THE SUTURE BROKE IN HALF. THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY HOWEVER, HE HAD TO GO THROUGH 2-3 MORE ADDITIONAL SUTURES BREAKING BEFORE GETTING ONES THAT HELD UP. HE DESCRIBED THE CHARACTERISTIC/PERFORMANCE OF THE FAILED SUTURES AS BRITTLE. A NEW SUTURE OF THE SAME TYPE WAS USED". NO PATIENT HARM OR INJURY. NO PART OF THE BROKEN SUTURE REMAINED IN THE PATIENT. SEE ASSOCIATED MDRS #3004365956-2023-00044, 3004365956-2023-00046, 3004365956-2023-00043.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259636 ↗
• MalfunctionMay 17, 2023Break; Material Separation; Break; Material Separation

  THE REPORT STATES "CAPIO SUTURE DART DETACHED DURING SUTURING MUSCLE AND WAS UNABLE TO BE RETRIEVED".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16945399 ↗
• MalfunctionFeb 13, 2023Material Separation; Material Separation

  REPORTED EVENT: TAPER CUT NEEDLE BROKE OFF. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369030 ↗