WECK IPN008818Recalls & reported problems
Teleflex Incorporated · VISISTAT 35R 6/BOX · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Teleflex Weck Visistat skin stapler is a staple used on the skin. Its 711 reports, none involving deaths or injuries, mostly describe staple jams, staples failing to fire or misfiring, and staples not forming properly. Recent reports say the skin was not captured properly and that jams forced a new stapler to be used. No recalls name this device, and reports in the last 12 months number 16, down from 231 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 711
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 711 adverse event reports that list this exact device (DI 04026704418190), received between May 13, 2021 and Mar 24, 2026 — classified as 711 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (500 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam500
- Failure to Fire32
- Misfire32
- Failure to Form Staple29
- Physical Resistance/Sticking28
- Firing Problem23
- Mechanical Problem16
- Failure to Align11
Patient problems
- No Clinical Signs, Symptoms or Conditions553
- Insufficient Information155
- Skin Inflammation/ Irritation3
- Abrasion2
- Skin Tears2
Recent adverse event reports
The 25 most recent of 711 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Failure to Form Staple
IT WAS REPORTED THAT "THE SKIN WAS NOT CAPTURED PROPERLY WHEN APPLYING THE STAPLE". NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: Insufficient Information
MAUDE report 24681543 ↗MalfunctionMar 24, 2026Failure to Form Staple
IT WAS REPORTED THAT "THE SKIN WAS NOT CAPTURED PROPERLY WHEN APPLYING THE STAPLE". NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: Insufficient Information
MAUDE report 24681479 ↗MalfunctionFeb 3, 2026Mechanical Jam
IT WAS REPORTED THAT THE "STAPLES DID NOT FIRE FROM THE STAPLER". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247892 ↗MalfunctionJan 30, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228493 ↗MalfunctionJan 19, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111493 ↗MalfunctionJan 16, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099989 ↗MalfunctionJan 9, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24023590 ↗MalfunctionDec 29, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "STAPLE DEFORMED". A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907138 ↗MalfunctionDec 23, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLE DEFORMED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877856 ↗MalfunctionDec 18, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT "TWO STAPLES WERE RELEASED AT ONCE." A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844015 ↗MalfunctionDec 12, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790167 ↗MalfunctionDec 8, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "IT WAS FOUND THAT THE STAPLER IS NOT FIRING DURING USE ON A PATIENT. THE PATIENT'S CONDITION IS FIND AND NO MEDICAL INTERVENTION REQUIRED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742684 ↗MalfunctionNov 27, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT "THE STAPLES WERE COMING OUT ASKEW." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23666261 ↗MalfunctionNov 14, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING." A NEW SET WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555106 ↗MalfunctionNov 13, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLE MISALIGNED." A NEW SET WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544287 ↗MalfunctionNov 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "THE STAPLER MALFUNCTIONED, IT JAMMED AND DELIVERED SEVERAL STAPLES AT ONCE. THE INCIDENT CONCERNED TWO DEVICES FROM THE SAME BATCH." NO REPORT OF PATIENT HARM OR INJURY. ASSOCIATED MDRS: 3003898360-2025-00807 AND 3003898360-2025-00811.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470774 ↗MalfunctionOct 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "THE STAPLER MALFUNCTIONED, IT JAMMED AND DELIVERED SEVERAL STAPLES AT ONCE". NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: Insufficient Information
MAUDE report 23426827 ↗MalfunctionOct 15, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT PRIOR TO USE IT WAS FOUND THAT THE STERILE PACKAGES WERE NOT SEALED PROPERLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292303 ↗MalfunctionOct 15, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT PRIOR TO USE IT WAS FOUND THAT THE STERILE PACKAGES WERE NOT SEALED PROPERLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292150 ↗MalfunctionOct 15, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT PRIOR TO USE IT WAS FOUND THAT THE STERILE PACKAGES WERE NOT SEALED PROPERLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291627 ↗MalfunctionSep 19, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "THE USER RELEASED THE HANDLE AFTER FIRING A STAPLE, BUT IT DID NOT RETURN TO THE ORIGINAL POSITION DURING USE. HE/SHE REPLACED THE STAPLER WITH A NEW UNIT, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE THIRD UNIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED". ASSOCIATED MDR # 3003898360-2025-00722.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097931 ↗MalfunctionSep 19, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "THE USER RELEASED THE HANDLE AFTER FIRING A STAPLE, BUT IT DID NOT RETURN TO THE ORIGINAL POSITION DURING USE. HE/SHE REPLACED THE STAPLER WITH A NEW UNIT, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE THIRD UNIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED". ASSOCIATED MDR # 3003898360-2025-00721.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097840 ↗MalfunctionSep 19, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT PRIOR TO USE, "STAPLE JAMMING". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097817 ↗MalfunctionSep 17, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075655 ↗MalfunctionSep 17, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074732 ↗
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- Appose ULC 8886803712Covidien LP · STAPLE, REMOVABLE (SKIN)68 reports
- Appose ULC 8886803512Covidien LP · STAPLE, REMOVABLE (SKIN)66 reports
- Proximate PXW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)37 reports
- Proximate PRW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)20 reports
- WECK IPN008820Teleflex Incorporated · STAPLE, REMOVABLE (SKIN)14 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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