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