Surefire Precision Infusion System SPS-21150-35Recalls & reported problems
Surefire Medical, Inc. · 150cm 0.021" Microcatheter w/ 3.5mm Expandable Tip · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857136004095), received between Jun 29, 2016 and Jun 29, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device-Device Incompatibility1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2016Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
THE PHYSICIAN WAS PREPARING TO PERFORM A LIVER EMBOLIZATION PROCEDURE. THE CELIAC ARTERY WAS ACCESSED USING A 5F ANGIOGRAPHIC CATHETER. THE SUREFIRE PRECISION INFUSION SYSTEM WAS INSERTED INTO THE ANGIOGRAPHIC CATHETER, BUT RESISTANCE WAS FELT AND THE DEVICE STOPPED ADVANCING. THE PHYSICIAN ATTEMPTED TO RETRACT THE SUREFIRE PRECISION FROM THE ANGIOGRAPHIC CATHETER, BUT THE DEVICE DID NOT MOVE. IN ACCORDANCE WITH THE IFU, THE PHYSICIAN WAS ADVISED BY A SUREFIRE REPRESENTATIVE TO STOP RETRACTING AGAINST RESISTANCE AND REMOVE THE SUREFIRE PRECISION AND THE ANGIOGRAPHIC CATHETER FROM THE PATIENT AS A SINGLE UNIT. AGAINST ADVICE, THE PHYSICIAN CONTINUED TO PULL ON THE SUREFIRE PRECISION, WHICH RESULTED IN BREAKAGE OF THE CATHETER SHAFT APPROXIMATELY 130CM FROM THE PROXIMAL END. THE TIP OF THE SUREFIRE PRECISION REMAINED LODGED IN THE ANGIOGRAPHIC CATHETER. THE ANGIOGRAPHIC CATHETER WITH THE SUREFIRE PRECISION TIP LODGED INSIDE WERE REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER ANGIOGRAPHIC CATHETER AND MICROCATHETER. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5759259 ↗
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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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