WECK IPN028493Recalls & reported problems
Teleflex Incorporated · VISISTAT 35W 6/BOX · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Visistat skin stapler from Teleflex is used to close skin wounds with staples. Its 561 reports mostly describe staplers that jam, arrive damaged or unsterile, have torn packaging, or fail to form staples, and most list no clinical signs in the patient. The reports include no deaths and 4 injuries. No recalls name this device.
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
- 564
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 564 adverse event reports that list this exact device (DI 14026704631787), received between Feb 4, 2021 and Sep 28, 2026 — classified as 4 injuries, 560 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (203 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 Jam203
- Device Damaged Prior to Receipt by User133
- Delivered as Unsterile Product53
- Tear, Rip or Hole in Device Packaging52
- Failure to Align50
- Failure to Form Staple27
- Difficult to Open or Close20
- Detachment of Device or Device Component13
Patient problems
- No Clinical Signs, Symptoms or Conditions519
- Insufficient Information38
- Impaired Healing6
- Skin Disorders4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Abscess1
- Hemorrhage/Blood Loss/Bleeding1
- Pain1
Recent adverse event reports
The 25 most recent of 564 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923764 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921502 ↗MalfunctionSep 28, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920563 ↗MalfunctionSep 20, 2023Failure to Fire; Failure to Fire
IT WAS REPORTED THAT "THE USER GRASPED THE HANDLE BUT THE STAPLE WAS NOT FIRED DURING USE. THEREFORE, HE/SHE REPLACED THE STAPLER WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO STAPLE FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT WAS REPORTED". THE CURRENT PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17784328 ↗MalfunctionSep 14, 2023Mechanical 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 17745467 ↗MalfunctionSep 14, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "THE STAPLERS FAILED TO FUNCTION (STAPLE JAMMING). PATIENT HAD NO ADVERSE REACTIONS". AS A RESULT, 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 17745405 ↗MalfunctionSep 14, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "THE STAPLERS FAILED TO FUNCTION (STAPLE JAMMING). PATIENT HAD NO ADVERSE REACTIONS". AS A RESULT, 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 17745382 ↗MalfunctionSep 14, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "THE STAPLERS FAILED TO FUNCTION (STAPLE JAMMING). PATIENT HAD NO ADVERSE REACTIONS". AS A RESULT, 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 17745363 ↗MalfunctionSep 14, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745343 ↗MalfunctionSep 14, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745328 ↗MalfunctionSep 14, 2023Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745304 ↗MalfunctionSep 13, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". THIS OCCURRED TO TWO STAPLERS. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDR #3003898360-2023-01338
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17740008 ↗MalfunctionSep 13, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". THIS OCCURRED TO TWO STAPLERS. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDR #3003898360-2023-01339.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17739954 ↗MalfunctionSep 7, 2023Mechanical 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 17699679 ↗MalfunctionSep 7, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT "THE PACKAGE WAS FOUND BROKEN DURING INSPECTION. INVOLVED 1338 PCS. ALL OF THE DEFECTS FOUND DURING THE SAME EXACT INSPECTION AT THE SAME TIME. THE OUTER BOX WAS NOT DAMAGED." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17698943 ↗MalfunctionSep 7, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT "THE PACKAGE WAS FOUND BROKEN DURING INSPECTION. INVOLVED 426 PCS. ALL OF THE DEFECTS FOUND DURING THE SAME EXACT INSPECTION AT THE SAME TIME. THE OUTER BOX WAS NOT DAMAGED". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17698689 ↗MalfunctionSep 6, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17692204 ↗MalfunctionSep 6, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17692164 ↗MalfunctionSep 6, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690003 ↗MalfunctionSep 6, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689997 ↗MalfunctionSep 1, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON A PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17670819 ↗MalfunctionSep 1, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT "THE PACKAGE WAS FOUND BROKEN DURING INSPECTION. INVOLVED 516 PCS. ALL OF THE DEFECTS FOUND DURING THE SAME EXACT INSPECTION AT THE SAME TIME. THE OUTER BOX WAS NOT DAMAGED." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17669880 ↗MalfunctionAug 30, 2023Crack; Crack
IT WAS REPORTED THAT "THE STAPLER CASING IS CRACKED." THIS WAS OBSERVED PRIOR TO USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17651940 ↗MalfunctionAug 29, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641312 ↗MalfunctionAug 29, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT "STAPLES WERE FOUND JAMMING PRIOR TO USE ON THE PATIENT." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641299 ↗
Other STAPLE, REMOVABLE (SKIN) devices
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- WECK IPN008818Teleflex Incorporated · STAPLE, REMOVABLE (SKIN)711 reports
- Proximate PMW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)131 reports
- 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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