TARGET M0035453080Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252600442), received between Dec 8, 2016 and Jan 13, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (2 reports).
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
- Premature Separation2
- Fracture1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Premature Separation
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064081 ↗MalfunctionMay 3, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE WHEN DELIVERING THE SUBJECT COIL TO ITS DESTINATION, THERE WAS RESISTANCE INSIDE THE MICROCATHETER. THE PHYSICIAN STARTED TO WITHDRAW THE SUBJECT COIL AND FELT THAT THERE WAS NO ANY RESISTANCE. THE SUBJECT COIL DETACHED FROM THE WIRE AND WAS PARTLY INSIDE THE MICROCATHETER. WITH A COIL PUSHER THE PHYSICIAN WAS ABLE TO GET THE SUBJECT COIL TO THE CORRECT DESTINATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16861562 ↗MalfunctionAug 4, 2021Fracture; Fracture
IT WAS INITIALLY REPORTED THAT DURING THE EMBOLISM OF PCOMA ANEURYSM, A GUIDE WIRE AND MICROCATHETER WERE USED TO DELIVERED THE A COIL (SUBJECT DEVICE) TO TARGET SITE. HOWEVER, THE SUBJECT COIL EXPERIENCED FRICTION AT THE PROXIMAL OF THE MICROCATHETER AND COULD NOT BE ADVANCED OUT OF THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL DELIVERY WIRE (SUBJECT DEVICE) WAS FOUND BROKEN/FRACTURE DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12278018 ↗MalfunctionDec 8, 2016Premature Activation; Premature Activation
BASED ON INVESTIGATION OF THE RETURNED PRODUCT, THE MAIN COIL DETACHED PREMATURELY INSIDE THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6156461 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page