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WECK IPN028492Recalls & reported problems

Teleflex Incorporated · VISISTAT 35R 6/BOX · Class 1

Quick summary

This Teleflex Visistat skin stapler has 1,377 FDA adverse event reports, with no deaths and no injuries. The reports mostly describe staples that will not come out of the stapler, mechanical jams, and staples that fail to fire or form. Some note no patient harm. 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
1,377
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,377 adverse event reports that list this exact device (DI 14026704631770), received between Feb 4, 2021 and Apr 8, 2024 — classified as 1,377 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (1,059 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

Nov 2023: 48 reportsDec 2023: 19 reportsJan 2024: 70 reportsFeb 2024: 27 reportsMar 2024: 37 reportsApr 2024: 15 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202670
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Jam1,059
  • Failure to Fire122
  • Failure to Form Staple52
  • Physical Resistance/Sticking32
  • Delivered as Unsterile Product19
  • Failure to Align18
  • Misfire15
  • Tear, Rip or Hole in Device Packaging14

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,100
  • Insufficient Information323
  • Autoimmune Disorder7
  • Pain1
  • Skin Tears1
  • Wound Dehiscence1

Recent adverse event reports

The 25 most recent of 1,377 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19061787 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19060852 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19060588 ↗
  • MalfunctionApr 8, 2024Failure to Form Staple; Failure to Form Staple

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19060543 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059759 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059730 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059695 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059562 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059424 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059327 ↗
  • MalfunctionApr 8, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19059294 ↗
  • MalfunctionApr 5, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19050108 ↗
  • MalfunctionApr 5, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19049985 ↗
  • MalfunctionApr 5, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE STAPLE WILL NOT COME OUT FROM THE STAPLER. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "NORMAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19049965 ↗
  • MalfunctionApr 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT "FAILURE TO FUNCTION. [THE HANDLE OF STAPLER IS STUCK AND CANNOT REBOUND AUTOMATICALLY]". 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 19033804 ↗
  • MalfunctionMar 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT "HOSPITAL REPORTED THAT OUR SKIN STAPLER GOT ISSUES CANNOT WORK TO CLOSE THE WOUND". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 19008396 ↗
  • MalfunctionMar 26, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT "MISFIRE/JAMMING - STAPLES NOT FIRING. NO PATIENT HARM". A 2ND STAPLER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18981240 ↗
  • MalfunctionMar 20, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE STAPLER JAMMED. 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 18942171 ↗
  • MalfunctionMar 20, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE STAPLER JAMMED. 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 18942150 ↗
  • MalfunctionMar 20, 2024Firing Problem; Firing Problem

    IT WAS REPORTED THAT "STAPLER IS LOCKING UP AND JAMMING WHEN IN USE". ADDITIONAL INFORMATION RECEIVED STATES THAT 3 DEVICES WERE USED ON ONE PATIENT. THERE WAS NO PATIENT HARM. A 4TH STAPLER FROM A DIFFERENT LOT NUMBER WORKED SUCCESSFULLY. NO MEDICAL INTERVENTION REQUIRED. SEE ASSOCIATED MDRS 3003898360-2024-00345 AND 3003898360-2024-00350.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18940570 ↗
  • MalfunctionMar 20, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT "STAPLER IS LOCKING UP AND JAMMING WHEN IN USE". ADDITIONAL INFORMATION RECEIVED STATES THAT 3 DEVICES WERE USED ON ONE PATIENT. THERE WAS NO PATIENT HARM. A 4TH STAPLER FROM A DIFFERENT LOT NUMBER WORKED SUCCESSFULLY. NO MEDICAL INTERVENTION REQUIRED. SEE ASSOCIATED MDRS 3003898360-2024-00345 AND 3003898360-2024-00349.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18940551 ↗
  • MalfunctionMar 19, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "DOCTORS USING STAPLER ON PATIENTS THEN IT GOT JAM, CANNOT WORK ANYMORE". 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 18929883 ↗
  • MalfunctionMar 15, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT "HOSPITAL REPORTED THAT OUR SKIN STAPLER GOT ISSUES CANNOT WORK TO CLOSE THE WOUND". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 18916380 ↗
  • MalfunctionMar 15, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT "HOSPITAL REPORTED THAT OUR SKIN STAPLER GOT ISSUES CANNOT WORK TO CLOSE THE WOUND". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 18914854 ↗
  • MalfunctionMar 15, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT "HOSPITAL REPORTED THAT OUR SKIN STAPLER GOT ISSUES CANNOT WORK TO CLOSE THE WOUND". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 18914759 ↗

Other STAPLE, REMOVABLE (SKIN) devices

All STAPLE, REMOVABLE (SKIN) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.