SHINOBI 547214XRecalls & reported problems
Cordis Corporation · SGW SHINOBI PLUS 300 CM · Class 2
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 10705032056533), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Delamination1
- Difficult to Remove1
- Kinked1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2018Bent; Kinked; Difficult to Remove; Delamination; Bent; Kinked; Difficult to Remove; Delamination
DURING USE IN PATIENT, IT WAS REPORTED THAT A SHINOBI + 300 CM .014" INTERVENTIONAL WIRE BECAME TANGLED ON ITSELF WITHIN THE BRACHIAL ARTERY AND BECAME STUCK UPON ATTEMPTS AT WITHDRAWAL. THE COATING SHRED OFF AND THE PIECES HAD TO REMOVE WITH SURGERY. THE WIRE WAS BEING USED FOR AN AORTO-ILIAC ANGIOGRAM WITH IVUS (.014" RX) AND AFTER THE PROCEDURE WAS COMPLETED, THE WIRE BECAME LOOPED ON ITSELF IN SEVERAL DIFFERENT PLACES WITHIN THE BRACHIAL ARTERY. ATTEMPTS AT WITHDRAWAL WERE UNSUCCESSFUL AND THE SURGEON NEEDED TO CUT THE WIRE TO EXTRACT IT. HOWEVER, THERE WERE SOME PIECES OF WHAT APPEARED TO BE THE COATING OF THE WIRE THAT HAD SHEARED OFF INSIDE THE ARTERY AFTER THE WIRE PIECES WERE REMOVED. ENDOVASCULAR ATTEMPTS (SNARING) WERE MADE WITHOUT SUCCESS. THE SURGEON ELECTED TO TAKE THE PATIENT TO THE OR AND PERFORM OPEN SURGERY TO REMOVE THE REMAINING PIECES OF THE WIRE. THE PATIENT IS FINE AND THERE WERE NO FURTHER COMPLICATIONS. THE PRODUCT WAS NOT RESTERILIZED. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE DID NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT RE-SHAPED BY THE USER. THE WIRE NOT USED FOR TREATMENT OF
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7285728 ↗
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- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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