WECK IPN917212Recalls & reported problems
Teleflex Incorporated · VISISTAT 35R 6/BOX · Class 1
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 14026704736284), received between Feb 4, 2026 and Sep 28, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (10 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
- Failure to Fire10
- Mechanical Jam10
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information2
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923551 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844261 ↗MalfunctionSep 14, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757056 ↗MalfunctionSep 14, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756994 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756951 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756907 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756886 ↗MalfunctionJul 27, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036641 ↗MalfunctionJul 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893866 ↗MalfunctionJul 1, 2026Failure to Fire
IT WAS REPORTED THAT "A INCIDENT OCCURRED ON (B)(6) 2026. IN THE ORTHOPEDICS DEPARTMENT, A DEFECTIVE STAPLER WAS USED. IT JAMMED AND THE STAPLES FAILED TO COME OUT." ADDITIONAL INFORMATION RECEIVED REPORTS THAT "THE WOUND EDGES WERE INFLAMED IMMEDIATELY POST-OPERATIVELY, BUT THE EVOLUTION OF THE CONDITION WAS POSITIVE" [FOR THE PATIENT]. NO MEDICAL INTERVENTION RELATED TO THIS INCIDENT WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678406 ↗MalfunctionMay 14, 2026Failure to Fire
IT WAS REPORTED THAT "DURING THE PROCEDURE, THE DEVICE FAILED TO FIRE WHILE BEING USE ON THE PATIENT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 25173547 ↗MalfunctionMay 11, 2026Failure to Fire
IT WAS REPORTED THAT "DURING THE PROCEDURE, THE DEVICE FAILED TO FIRE WHILE BEING USED ON THE PATIENT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 25139610 ↗MalfunctionApr 23, 2026Failure to Fire
IT WAS REPORTED THAT "THE FIRST STAPLE COULD NOT BE FIRED DURING USE. THEREFORE, THE STAPLER WAS REPLACED WITH A NEW UNIT TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24970980 ↗MalfunctionApr 22, 2026Mechanical Jam
IT WAS REPORTED "STAPLES JAMMING". THE USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955558 ↗MalfunctionApr 22, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING." THE USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952753 ↗MalfunctionApr 22, 2026Failure to Fire
IT WAS REPORTED THAT "THE STAPLES WERE NOT FIRED DURING THE TEST BEFORE USE. THEREFORE, ANOTHER STAPLER WAS USED INSTEAD." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952682 ↗MalfunctionApr 14, 2026Mechanical Jam
IT WAS REPORTED THAT " STAPLE JAMMING". ADDITIONAL INFORMATION RECEIVED ON MARCH 22, 2026, INDICATED THAT "A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877539 ↗MalfunctionMar 9, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552162 ↗MalfunctionMar 9, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING." A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551931 ↗MalfunctionFeb 5, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269093 ↗MalfunctionFeb 4, 2026Mechanical Jam
IT WAS REPORTED THAT "STAPLE JAMMING". A NEW STAPLER WAS USED TO PROCEED WITH THE PROCEDURE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264161 ↗
Other Stapler, skin devices
- WECK IPN917213Teleflex Incorporated · Stapler, skin87 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.