WECK IPN917213Recalls & reported problems
Teleflex Incorporated · VISISTAT 35W 6/BOX · Class 1
All models of WECK (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Teleflex VISISTAT skin stapler is used to close skin during surgery. The 67 reports filed since February 2026 mostly describe staplers jamming during use on a patient, plus staplers failing to fire, misaligning, or failing to form a proper staple. Reports mention no deaths and one injury; 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
- 87
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 14026704736291), received between Feb 3, 2026 and Sep 2, 2026 — classified as 1 injury, 86 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (70 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
- Mechanical Jam70
- Failure to Fire13
- Failure to Align3
- Failure to Form Staple2
- Difficult to Open or Close1
- Misfire1
- Unintended Movement1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions86
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563524 ↗MalfunctionAug 18, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300651 ↗MalfunctionAug 17, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289258 ↗MalfunctionAug 17, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289153 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072916 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072846 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072824 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072263 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072262 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071982 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071979 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071710 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071706 ↗MalfunctionJul 29, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071551 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071545 ↗MalfunctionJul 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071449 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893854 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893718 ↗MalfunctionJul 21, 2026Mechanical Jam
IT WAS REPORTED THAT ""[THE]" STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT." NO PATIENT INJURY OR HARM REPORTED. NO MEDICAL INTERVENTION REPORTED. PATIENT CONDITION REPORTED TO BE "FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893702 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893588 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893579 ↗MalfunctionJul 21, 2026Mechanical Jam
IT WAS REPORTED THAT""[THE]" STAPLES WERE FOUND JAMMING DURING USE ON THE PATIENT." NO PATIENT INJURY OR HARM REPORTED. NO MEDICAL INTERVENTION REPORTED. PATIENT CONDITION REPORTED TO BE "FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892513 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25891737 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25891726 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25891302 ↗
Other Stapler, skin devices
- WECK IPN917212Teleflex Incorporated · Stapler, skin21 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 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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