Target M0035432030Recalls & reported problems
Stryker Corporation · Helical Ultra Detachable Coil · Class 2 · Implant
All models of TARGET (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540675996), received between Jan 11, 2019 and Dec 11, 2019 — classified as 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2019Fracture; Fracture
IT WAS REPORTED WHILE ADVANCING THE COIL (SUBJECT DEVICE) INTO THE MICROCATHETER THERE WAS FRICTION AND THE COIL COULD NOT BE ADVANCED TO THE TARGET LESION. WHEN WITHDRAWN FROM THE CATHETER, THE COIL WAS MISSING. THE OPERATOR THEN USED A GUIDEWIRE TO ADVANCE THE MICROCATHETER AND RETRIEVE THE COIL. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9451436 ↗MalfunctionJan 11, 2019Break; Break
ANALYSIS OF THE DEVICE REVEALED THAT THE COIL DELIVERY WIRE WAS BROKE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242491 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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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