CAPIORecalls & reported problems across all models

We found 4 models of CAPIO by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2021 and Dec 21, 2023 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CAPIO problems

CAPIO models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CAPIO IPN000859

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  7 reports
• CAPIO IPN000861

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
  7 reports
• CAPIO IPN000860

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
  6 reports
• CAPIO IPN000858

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report

Recent CAPIO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Break; Break

  "IT WAS REPORTED THAT DURING USE ON A PATIENT, "THERE WERE TIMES WHEN THE NEEDLE PART AND SUTURE BREAKS". NO PATIENT HARM OR INJURY. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373668 ↗
• MalfunctionMar 10, 2023Material Separation; Material Separation

  REPORTED ISSUE: WHILE USING THE SUTURES PLACEMENT DEVICE, THAT IT WAS IMPOSSIBLE TO PROPERLY RECOVER THE DART. THE RESCUE WIRE WAS USED TO RETRIEVE IT. THE CONSEQUENCE FOR THE PATIENT IS AN INCREASE IN THE INTERVENTION TIME BY A FEW MINUTES. THIS IS AN ISOLATED INCIDENT. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522172 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  REPORTED EVENT: THE SURGEON LOADED THE POLYPROPYLENE SUTURE INTO CAPIO SLIM DEVICE CORRECTLY AND ALL ENGAGED CORRECTLY. HE SAID THAT AS HE DEPRESSED THE CAPIO SLIM PLUNGER WHILE ON THE SACROSPINOUS LIGAMENT AND RETRACTED IT, THE SUTURE WAS BROKEN AT THE CAPIO HEAD, AND THE DART END HAD SNAPPED OFF THE SUTURE AND WAS STILL IN THE CARRIAGE OF THE CAPIO. HE WAS ABLE TO REMOVE THE DART FROM THE CAPIO CARRIAGE/HEAD AND USE ANOTHER POLYPROPYLENE SUTURE TO COMPLETE THE CASE SUCCESSFULLY. THIS TIME THE SUTURE WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373205 ↗
• MalfunctionJan 24, 2023Material Separation; Material Separation

  REPORTED EVENT: A CAPIOSLIM NEEDLE WOULD NOT GO INTO THE CAPIO HOLE SUCCESSFULLY AND AFTER REPEATED ATTEMPTS THE SUTURE NEEDLE DETACHED AND WAS LEFT INSIDE THE PATIENT. THE REPORT STATES NO INJURY AS THE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234205 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CAPIO LOADED WITH A BULLET WAS INSERTED INTO THE PATIENT BY THE SURGEON. UPON WITHDRAWING THE INSTRUMENT IT WAS NOTED BY THE SURGEON THAT THE BULLET TIP WAS NO LONGER ATTACHED TO ITS SUTURE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 14116308 ↗
• MalfunctionMar 1, 2022Break; Break

  WHEN THE SUTURE WAS FIRED USING CAPIO SLIM, ONLY THE TIP OF THE NEEDLE FELL INTO THE PATIENT'S BODY; THUS, ANOTHER ONE WAS USED, THE NEEDLE WAS RECOVERED, AND THE OPERATION WAS COMPLETED. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635963 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CAPIO NEEDLE BROKE OFF. NEW DEVICE USED. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176573 ↗

Other Teleflex Incorporated products

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• HUDSON RCI152 models · 1,461 reports · 7 recalls
• LANGSTON4 models · 15 reports · 5 recalls
• PLEUR-EVAC15 models · 146 reports · 1 recall
• LMA AIRWAY MANAGEMENT47 models · 139 reports
• UROLIFT13 models · 137 reports