CAPIO IPN000860Recalls & reported problems
Teleflex Incorporated · Polypropylene Blue Monofilament Size 0 48" TC-43 Needle BSC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704603883), received between Jan 6, 2022 and Mar 10, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation3
- Detachment of Device or Device Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗
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- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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