STABILIZER 527300ERecalls & reported problems
Cordis Corporation · SGW .014 STABILIZER 300CM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032056410), received between May 2, 2017 and Mar 31, 2024 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment Of Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2024Fracture; Fracture
AS REPORTED, WHEN THE .014 300CM STABILIZER WAS USED WITH OUTBACK CATHETER, IT WASN'T GOING THROUGH AS SMOOTHLY. THE RADIOLOGIST FELT A LOT OF RESISTANCE. WHEN TAKING THE WIRE OUT, THE DISTAL TIP CAME OFF GOT STUCK INSIDE THE PATIENT. A SNARE WAS THEN USED TO REMOVE IT SUCCESSFULLY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009318 ↗InjuryMay 2, 2017Detachment Of Device Component; Detachment Of Device Component
CUSTOMER REPORTS DURING PERIPHERAL INTERVENTION, A PIECE OF THE DISTAL TIP OF A .014" STABILIZER XS WIRE SHEARED OFF INSIDE THE PATIENT'S DISTAL PERONEAL ARTERY. THE PHYSICIAN USED A 2 X 40 MM SABER TO DILATE THE LESION AND SECURE THE PIECE OF THE WIRE IN PLACE. PATIENT WAS TREATED WITH ANGIOPLASTY BALLOONS TO SEE IF THE WIRE TIP WOULD MIGRATE, BUT OTHERWISE WAS FURTHER IMPLANTED INTO THE INTIMA OF THE ARTERY. THERE WAS DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL AND LESION AS THERE WAS CALCIUM IN THE TARGET LESION THAT THE WIRE WAS UNABLE TO SUCCESSFULLY NEGOTIATE. THERE WERE NO PATIENT INJURY. THE DISTAL TIP MUST HAVE KINKED WHEN SEVERAL ATTEMPTS TO ADVANCE PAST THE LESION WERE MADE, AND AGAIN WHEN SUBSEQUENT UNSUCCESSFUL WITHDRAWAL ATTEMPTS WERE MADE. THERE WAS A FOCAL STENOSIS APPROXIMATELY 20 MM IN LENGTH IN THE DISTAL PERONEAL ARTERY THAT WAS CALCIFIED. THE PHYSICIAN BELIEVES THAT WHEN HE WAS ATTEMPTING TO ADVANCE THE WIRE BEYOND THE LESION, THE WIRE MAY HAVE TRAVELED SUBINTIMALLY AND PROLAPSED SLIGHTLY, CAUSING A KINK THAT CAUGHT ON CALCIUM IN THE SUBINTIMAL LAYER. WHEN HE ATTEMPTED TO WITHDRAW AND ADVANCE THE WIRE, IT WAS STUCK AND THE DISTAL TIP, APPROXIMATELY 15 MM IN
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6536511 ↗
Other Wire, guide, catheter devices
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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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