DEKNATEL IPN028965Recalls & reported problems
Teleflex Incorporated · DEKLENE MAXX BLUE MONOFILAMENT 6-0 XT-1 2N 30"X4 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704637031), received between Dec 3, 2024 and Dec 3, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT "NEEDLE IS POPPING OFF OF SUTURE DURING PROCEDURE". ADDITIONAL INFORMATION RECEIVED STATES THAT "WHEN THE SURGEON IS TYING KNOTS OR WHEN HE GOES THROUGH THE VEIN GRAFT AND PULLS UP, THE NEEDLE IS POPPING OFF EASILY. AT LEAST 2 EXTRA PACKS WERE OPENED TO GET ON THAT DIDN'T POP OFF. ALL WERE FROM SAME LOT NUMBER. IT APPEARS TO BE FROM THE SAME EVENT. NO OTHER INFORMATION WAS PROVIDED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS # 3004365956-2024-00086 AND 3004365956-2024-00088.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832226 ↗MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT "NEEDLE IS POPPING OFF OF SUTURE DURING PROCEDURE". ADDITIONAL INFORMATION RECEIVED STATES THAT "WHEN THE SURGEON IS TYING KNOTS OR WHEN HE GOES THROUGH THE VEIN GRAFT AND PULLS UP, THE NEEDLE IS POPPING OFF EASILY. AT LEAST 2 EXTRA PACKS WERE OPENED TO GET ON THAT DIDN'T POP OFF. ALL WERE FROM SAME LOT NUMBER. IT APPEARS TO BE FROM THE SAME EVENT. NO OTHER INFORMATION WAS PROVIDED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS # 3004365956-2024-00086 AND 3004365956-2024-00087.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832210 ↗MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT "NEEDLE IS POPPING OFF OF SUTURE DURING PROCEDURE". ADDITIONAL INFORMATION RECEIVED STATES THAT "WHEN THE SURGEON IS TYING KNOTS OR WHEN HE GOES THROUGH THE VEIN GRAFT AND PULLS UP, THE NEEDLE IS POPPING OFF EASILY. AT LEAST 2 EXTRA PACKS WERE OPENED TO GET ON THAT DIDN'T POP OFF. ALL WERE FROM SAME LOT NUMBER. IT APPEARS TO BE FROM THE SAME EVENT. NO OTHER INFORMATION WAS PROVIDED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS # 3004365956-2024-00088 AND 3004365956-2024-00087.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832199 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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