TARGET M0035478200Recalls & reported problems
Stryker Corporation · 360 Soft Detachable Coil · Class 2 · Implant
All models of TARGET (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676597), received between Dec 6, 2016 and Sep 16, 2022 — classified as 1 death, 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fracture1
Patient problems
- Embolism/Embolus1
- Hernia1
- No Consequences Or Impact To Patient1
- Stroke/CVA1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathSep 16, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING RUPTURED ANEURYSM, WHEN PHYSICIAN TRIED TO REPOSITION THE SUBJECT COIL, IT WAS STUCK IN THE CATHETER AND DID NOT MOVE AT ALL. PHYSICIAN TRIED TO RETRACT THE SUBJECT COIL BUT WAS UNSUCCESSFUL, SO USED A SNAIL AND A STENT RETRIEVER AS A MEDICAL INTERVENTION. WHEN REMOVED THE SUBJECT COIL FOUND THAT THE LAST LOOP WAS HOOKED IN ANOTHER HOOP, AND IT WAS STRETCHED COMPLETELY. THERE WAS A SURGICAL DELAY OF 5 HOURS. AS A RESULT, THE PATIENT HAD A BIG STROKE ON THE LEFT SIDE. THE PATIENT HAS ANOTHER ANEURYSM ON THE OTHER SIDE THAT INITIALLY WANTED TO TREAT AT THE SAME TIME, BUT IT COULD NOT BE TREATED. PHYSICIAN DECIDED TO PROCEED IN THE COMING DAYS. PATIENT CURRENT STATUS IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Embolism/Embolus; Hernia; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 15439906 ↗MalfunctionDec 6, 2016Break; Break
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL FRACTURED IN THE (NON-STRYKER) MICROCATHETER. THE COIL AND THE MICROCATHETER WERE REMOVED ALTOGETHER AS ONE UNIT. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6147450 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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