TAUT IPN028436Recalls & reported problems
Teleflex Incorporated · Class 2
All models of TAUT (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14026704629586), received between Feb 9, 2022 and Feb 9, 2022 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 reports).
3 other recalls cover devices cleared under the same FDA submission (K010007); they may or may not involve this specific model.
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
- Delivered as Unsterile Product7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500478 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500454 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500437 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500410 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500383 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500373 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
INTUITIVE SURGICAL DETECTED FAILED STERILE BARRIER AT INCOMING INSPECTION. THE FAILED STERILE BARRIER APPEARS (PICTURES) TO BE DUE TO A POOR HEAT SEAL. INTUITIVE SURGICAL COMPLAINT NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500330 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K010007. One submission often covers many models, so check the product and lot details in each record.
- Z-1326-2014 · Mar 11, 2014 · Terminated5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide
- Z-1279-2014 · Mar 11, 2014 · Terminated5/10 mm Weck, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or
- Z-1284-2014 · Mar 11, 2014 · Terminated5/10/12 mm Weck Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of
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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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