Skip to content

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

All STAPLE, REMOVABLE (SKIN) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page