VSI IPN916047Recalls & reported problems
Teleflex Incorporated · 7274V · Class 2
All models of VSI (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156106997), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: IN THE PROCESS OF GETTING MORE INFORMATION. CATH LAB MANAGER SENT EMAIL STATING "WE HAD A MICRO-INTRODUCER SHEAR OFF INTO A PATIENT'S ARTERY THIS WEEK. I HAVE RETAINED THE PIECE OF THE INTRODUCER THAT CAME OUT AND THE PACKAGING. WE DID SEND THE PATIENT TO HAVE THE OTHER PIECE SURGICALLY REMOVED." ADDITIONAL INFORMATION RECEIVED 27DEC2021: PHYSICIAN STATED: IT WAS NOT THE FAULT OF OUR MICRO INTRODUCER KIT AS IT WAS USED ON A PATIENT THAT KNOWING HAD VERY FIBROTIC TISSUE WHICH CAUSED THE MALFUNCTION. IN HINDSIGHT, HE STATED THAT IT WOULD HAVE BEEN BETTER TO NOT USE THE MIK AND TO HAVE A VASCULAR SURGEON CUT DOWN FOR ACCESS. WHEN THE PATIENT WAS SENT TO SURGERY TO HAVE THE REMAINING PIECE REMOVED, PHYSICIAN STATED THAT THE SURGEON WAS AMAZED AT HOW FIBROTIC THE TISSUE WAS AND WOULD NEED TO BE REMOVED BEFORE THE COULD ACCESS THE VESSEL.
Patient problems: Foreign Body In Patient
MAUDE report 13171781 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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