TARGET M0035452560Recalls & reported problems
Stryker Corporation · Helical Nano Detachable Coil · Class 2 · Implant
All models of TARGET (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252600411), received between Aug 23, 2017 and Jun 7, 2021 — classified as 3 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 16, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
- Premature Separation1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2021Premature Separation; Premature Separation
DURING CLINICAL COILING PROCEDURE FOR AN ANEURYSM LOCATED AT THE MIDDLE CEREBRAL ARTERY (MCA), THE ANEURYSM WAS FRAMED WITH 2-TRENZA DEVICES (8MM /6MM) AND 4-TARGET COILS WERE DEPLOYED. IT WAS REPORTED THAT THE NEXT TARGET COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE IN THE INTRODUCER SHEATH AND BETWEEN COIL DELIVERY SYSTEM. THE SUBJECT COIL WAS ABLE TO PULL BACK AND IT WOULD NOT ADVANCE FORWARD. THE COIL (SUBJECT DEVICE) WAS PARTIALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN PULLED BACK CATHETER AND WAS ATTEMPTED AGAIN AFTER REPOSITIONING THE MICROCATHETER AND COULD NOT PUSH THE COIL (SUBJECT DEVICE) OUT THE SECOND TIME. SINCE A TOTAL OF 4 TARGET COILS ALREADY DEPLOYED, THE PHYSICIAN DECIDED NOT PUTTING IN ANY MORE COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11951174 ↗MalfunctionApr 9, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL EXPERIENCED DIFFICULTY ADVANCING WITHIN AND OUT OF THE MICROCATHETER. UPON REMOVAL THE SUBJECT DEVICE HAD FRACTURED WITHIN THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9942097 ↗MalfunctionAug 23, 2017Break; Break
DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE DELIVERY WIRE WAS BROKEN. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6815513 ↗
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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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