WECK IPN008819Recalls & 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
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04026704600762), received between Feb 17, 2021 and Apr 10, 2023 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (8 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.
Most reported problems
Device problems
- Mechanical Jam8
- Activation, Positioning or Separation Problem1
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT DURING PRODUCT INSPECTION A PACKAGE WAS FOUND "BROKEN". UPON FURTHER REVIEW, THE DAMAGE OCCURRED TO ALL 106 PIECES. ALL PIECES ARE FROM THE SAME LOT NUMBER. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16709423 ↗MalfunctionJul 7, 2021Mechanical Jam; Mechanical Jam
SOME STAPLES DID NOT COME OUT SMOOTHLY FROM THE DEVICE THEREFORE, A NEW UNIT WAS USED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12127254 ↗MalfunctionJul 7, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
STAPLES DID NOT COME OUT FROM THE DEVICE THEREFORE, A NEW UNIT WAS USED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12127226 ↗MalfunctionFeb 18, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON (B)(6) 2021, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342243 ↗MalfunctionFeb 17, 2021Mechanical Jam
IT WAS REPORTED THAT (B)(6) 2020, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339717 ↗MalfunctionFeb 17, 2021Mechanical Jam
IT WAS REPORTED THAT (B)(6) 2021, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339696 ↗MalfunctionFeb 17, 2021Mechanical Jam
IT WAS REPORTED THAT (B)(6) 2021, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339673 ↗MalfunctionFeb 17, 2021Mechanical Jam
IT WAS REPORTED THAT (B)(6) 2021, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339648 ↗MalfunctionFeb 17, 2021Mechanical Jam
IT WAS REPORTED THAT (B)(6) 2021, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339575 ↗MalfunctionFeb 17, 2021Mechanical Jam
IT WAS REPORTED THAT (B)(6) 2021, THE STAPLE WAS FOUND JAMMING AND COULD NOT BE FIRED PRIOR TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339539 ↗
Other STAPLE, REMOVABLE (SKIN) devices
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- WECK IPN028493Teleflex Incorporated · STAPLE, REMOVABLE (SKIN)564 reports
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- Proximate PXW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)37 reports
- Proximate PRW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)20 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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