Steerable Introducer Sheath 12F SS120065Recalls & reported problems
Freudenberg Medical, LLC · The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. · Class 2
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 00850004312049), received between May 10, 2021 and May 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
Patient problems
- Unspecified Vascular Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT WHILE USING THE SHEATH DURING A PATIENT PROCEDURE THE BALLOON RUPTURED IN THE HEART. THE PATIENT'S CHEST HAD TO BE OPENED SO THE THAT THE DEVICE COULD BE MANUALLY REMOVED. THE PATIENT IS REPORTEDLY STABLE AFTER THE PROCEDURE.
Patient problems: Unspecified Vascular Problem
MAUDE report 11796590 ↗
Other Catheter, Steerable devices
- FARADRIVE™ M004PF21M402Boston Scientific Corporation · CATHETER, STEERABLE1 recall15 deaths2,303 reports
- MITRACLIP SGC0701Abbott Vascular Inc. · CATHETER, STEERABLE17 deaths963 reports
- STEERABLE GUIDE CATHETER SGC0301Abbott Vascular Inc. · CATHETER, STEERABLE5 deaths389 reports
- FlexCath Advance™ 4FC12Medtronic, Inc. · CATHETER, STEERABLE6 deaths167 reports
- FlexCath Contour™ 10FCC13Medtronic, Inc. · CATHETER, STEERABLE2 deaths115 reports
- FlexCath Advance™ 4FC12Medtronic, Inc. · CATHETER, STEERABLE4 deaths61 reports
- FlexCath Advance™ 4FC12Medtronic, Inc. · CATHETER, STEERABLE4 deaths60 reports
- FlexCath Advance™ 4FC12Medtronic, Inc. · CATHETER, STEERABLE59 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.
How reports and recalls are matched · Editorial policy · Report an error on this page