transGlide Expandable Introducer 20F transGlide Expandable IntroducerRecalls & reported problems
Trans Aortic Medical Inc · 20F transGlide Expandable Introducer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00866697000224), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 death.
The most frequently reported specific device problem is “Detachment Of 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 Component1
- Difficult to Insert1
- Physical Resistance1
Patient problems
- Collapse1
- Death1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 29, 2017Detachment Of Device Component; Difficult to Insert; Physical Resistance
ON SEP. 4, 2017, TRANSAORTIC MEDICAL RECEIVED AN EMAIL FROM OUR EU DISTRIBUTOR REGARDING AN EVENT THAT OCCURRED ON (B)(6) 2017: OUR DEVICE, THE TRANSGLIDE EXPANDABLE INTRODUCER WAS USED DURING A TAVI PROCEDURE. DURING INSERTION OF THE SHEATH, THE PHYSICIAN FELT A SLIGHT RESISTANCE BUT THE INTRODUCER WAS ABLE TO ENTER INTO THE VESSEL WITHOUT ANY PROBLEM. UPON EXTRACTING THE TRANSGLIDE, THE PATIENT COMPLAINED OF PAIN. AT THIS MOMENT, PRESSURE LEVELS OF THE PATIENT DROPPED AND A CARDIAC MASSAGE WAS PERFORMED. DOCTORS THEN ANALYZED VIA ANGIOGRAPHY THE ANATOMY OF PATIENT AND IT WAS NOTICED THAT THERE WAS A RUPTURE IN THE RIGHT COMMON ILIAC ARTERY. IMMEDIATELY, A PERIPHERAL BALLOON WAS INFLATED ABOVE THE LESION TO STOP THE BLEEDING AND THE VASCULAR SURGEON WAS CALLED TO FIX THE ARTERY. THEY PUT 4 COVERED STENTS INTO THE VESSEL TO FIX THE RUPTURE WITH A GOOD RESULT. THE PATIENT WAS STABLE. HOWEVER, ON (B)(6) 2017 (TRANSAORTIC MEDICAL WAS INFORMED ON SEPTEMBER 4, 2017), THE PATIENT INVOLVED IN THIS PROCEDURE PASSED AWAY FROM RETROPERITONEAL BLEEDING AND GLOBAL DETERIORATION. ADDITIONAL INFORMATION WAS RECEIVED FROM ATTENDING PHYSICIAN (DR. (B)(6)): "THE PRE-TAVI STUDY SHOWED A PATIENT WITH
Patient problems: Collapse; Death; Hemorrhage/Blood Loss/Bleeding
MAUDE report 6905612 ↗
Other Introducer, Catheter devices
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- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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