VSI IPN029486Recalls & reported problems
Teleflex Incorporated · VSI Micro-Introducer Kit · Class 2
All models of VSI (31)
Data updated Oct 16, 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 10841156102890), received between Jun 19, 2020 and Jun 19, 2020 — 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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: PHYSICIAN WAS ATTEMPTING TO GAIN ACCESS TO RFA WITH THE MICRO-INTRODUCER. IT IS REPORTED, THAT THE PATIENT HAD A LOT OF FIBROUS TISSUE. DURING USE, THE MICRO-INTRODUCER HUB BROKE OFF AND THE SHAFT REMAINED IN THE PATIENT; THE CASE WAS ABORTED, AND PATIENT WAS SENT TO THE OR TO REMOVE SHAFT. ADDITIONAL INFORMATION RECEIVED 18JUN2020: PATIENT WAS FINE AFTER LEAVING THE OPERATING ROOM. REPORTED THAT THE PATIENT WAS STABLE THE WHOLE TIME, AND NO RESIDUAL ISSUES SINCE.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 10173596 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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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