TARGETRecalls & reported problems across all models
Stryker Corporation · 114 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,077
- Deaths reported
- 5
- Injuries reported
- 254
- Recalls
- 0
We found 114 models of TARGET by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 1,077 adverse event reports in the FDA's MAUDE database, received between May 6, 2016 and Sep 25, 2026 — classified as 5 deaths, 254 injuries, 817 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (448 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TARGET problems
Device problems
- Premature Separation448
- Fracture246
- Break124
- Adverse Event Without Identified Device or Use Problem111
- Premature Activation65
- Migration56
- Migration or Expulsion of Device39
- Expulsion30
Patient problems
- No Clinical Signs, Symptoms or Conditions566
- No Consequences Or Impact To Patient300
- No Known Impact Or Consequence To Patient67
- Foreign Body In Patient24
- Headache23
- Thrombosis14
- Thrombosis/Thrombus13
- No Patient Involvement11
TARGET models
114 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- TARGET M0035421030Device, Vascular, for Promoting Embolization55 reports
- TARGET M0035442040DEVICE, NEUROVASCULAR EMBOLIZATION49 reports
- TARGET M0035421540Device, Vascular, for Promoting Embolization35 reports
- TARGET M0035421020Device, Vascular, for Promoting Embolization33 reports
- TARGET M0035431020DEVICE, NEUROVASCULAR EMBOLIZATION32 reports
- TARGET M0035421530DEVICE, NEUROVASCULAR EMBOLIZATION31 reports
- TARGET M0035421520DEVICE, NEUROVASCULAR EMBOLIZATION30 reports
- TARGET M0035422060DEVICE, NEUROVASCULAR EMBOLIZATION29 reports
- TARGET M0035423060Device, Vascular, for Promoting Embolization26 reports
- TARGET M0035443060Device, Vascular, for Promoting Embolization26 reports
- TARGET M0035424150DEVICE, NEUROVASCULAR EMBOLIZATION1 death25 reports
- TARGET M0035442030Device, Vascular, for Promoting Embolization25 reports
- TARGET M0036181040DEVICE, NEUROVASCULAR EMBOLIZATION23 reports
- TARGET M0035422040DEVICE, NEUROVASCULAR EMBOLIZATION22 reports
- TARGET M0035476300Device, Vascular, for Promoting Embolization21 reports
- TARGET M0035431030Device, Vascular, for Promoting Embolization20 reports
- TARGET M0036181240Device, Vascular, for Promoting Embolization20 reports
- TARGET M0035442540DEVICE, NEUROVASCULAR EMBOLIZATION19 reports
- TARGET M0035475200Device, Vascular, for Promoting Embolization18 reports
- TARGET M0035423100Device, Vascular, for Promoting Embolization17 reports
- TARGET M0036180640Device, Vascular, for Promoting Embolization17 reports
- TARGET M0035476200Device, Vascular, for Promoting Embolization16 reports
- TARGET M0035474150Device, Vascular, for Promoting Embolization15 reports
- TARGET M0035452060Device, Vascular, for Promoting Embolization15 reports
- TARGET M0036180840DEVICE, NEUROVASCULAR EMBOLIZATION15 reports
- TARGET M0036180520Device, Vascular, for Promoting Embolization14 reports
- TARGET M0035425150Device, Vascular, for Promoting Embolization1 death13 reports
- TARGET M0035475150Device, Vascular, for Promoting Embolization13 reports
- TARGET M0035422540Device, Vascular, for Promoting Embolization12 reports
- TARGET M0036181450Device, Vascular, for Promoting Embolization12 reports
- Target M0035432080DEVICE, NEUROVASCULAR EMBOLIZATION11 reports
- TARGET M0035473060Device, Vascular, for Promoting Embolization11 reports
- TARGET M0035478300DEVICE, NEUROVASCULAR EMBOLIZATION11 reports
- TARGET M0035431010DEVICE, NEUROVASCULAR EMBOLIZATION11 reports
- TARGET M0035474100DEVICE, NEUROVASCULAR EMBOLIZATION1 death11 reports
- TARGET M0035423080DEVICE, NEUROVASCULAR EMBOLIZATION10 reports
- TARGET M0035424080Device, Vascular, for Promoting Embolization10 reports
- TARGET M0035452040DEVICE, NEUROVASCULAR EMBOLIZATION10 reports
- TARGET M0035422030DEVICE, NEUROVASCULAR EMBOLIZATION9 reports
- TARGET M0035423040Device, Vascular, for Promoting Embolization9 reports
- TARGET M0035431530DEVICE, NEUROVASCULAR EMBOLIZATION9 reports
- TARGET M0036182450DEVICE, NEUROVASCULAR EMBOLIZATION9 reports
- Target M0035432060Device, Vascular, for Promoting Embolization8 reports
- TARGET M0035474080DEVICE, NEUROVASCULAR EMBOLIZATION8 reports
- TARGET M0035443560DEVICE, NEUROVASCULAR EMBOLIZATION8 reports
- TARGET M0036182050Device, Vascular, for Promoting Embolization8 reports
- Target M0035433100Device, Vascular, for Promoting Embolization7 reports
- Target M0035434150Device, Vascular, for Promoting Embolization7 reports
- TARGET M0035477200DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- TARGET M0035477300DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- TARGET M0035431520Device, Vascular, for Promoting Embolization7 reports
- TARGET M0035424100DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- TARGET M0035466300Device, Vascular, for Promoting Embolization7 reports
- TARGET M0035443040DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- TARGET M0036180820DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- TARGET M0035424060Device, Vascular, for Promoting Embolization6 reports
- TARGET M0035425100DEVICE, NEUROVASCULAR EMBOLIZATION6 reports
- Target M0035433060DEVICE, NEUROVASCULAR EMBOLIZATION6 reports
- TARGET M0035473080DEVICE, NEUROVASCULAR EMBOLIZATION6 reports
- TARGET M0035475100Device, Vascular, for Promoting Embolization6 reports
- TARGET M0035431540Device, Vascular, for Promoting Embolization6 reports
- TARGET M0036181650DEVICE, NEUROVASCULAR EMBOLIZATION6 reports
- Target M0035434080Device, Vascular, for Promoting Embolization5 reports
- TARGET M0035477150DEVICE, NEUROVASCULAR EMBOLIZATION5 reports
- TARGET M0035479300DEVICE, NEUROVASCULAR EMBOLIZATION4 reports
- TARGET M0035473510DEVICE, NEUROVASCULAR EMBOLIZATION4 reports
- TARGET M0035461540Device, Vascular, for Promoting Embolization4 reports
- TARGET M0035453080Device, Vascular, for Promoting Embolization4 reports
- TARGET M0036182250DEVICE, NEUROVASCULAR EMBOLIZATION4 reports
- TARGET M0036180620DEVICE, NEUROVASCULAR EMBOLIZATION4 reports
- Target M0035432020Device, Vascular, for Promoting Embolization3 reports
- Target M0035433080DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0035467200DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0035476150DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- Target M0036154080DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0035424510DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0035471230DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0035465200Device, Vascular, for Promoting Embolization3 reports
- TARGET M0035452030DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0035452560Device, Vascular, for Promoting Embolization3 reports
- TARGET M0036181850DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- TARGET M0036180630Device, Vascular, for Promoting Embolization3 reports
- Target M0035432030DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- Target M0035432040DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- Target M0035432540Device, Vascular, for Promoting Embolization2 reports
- Target M0035432560DEVICE, NEUROVASCULAR EMBOLIZATION1 death2 reports
- Target M0035434060DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035461030Device, Vascular, for Promoting Embolization2 reports
- TARGET M0035466150DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035466200Device, Vascular, for Promoting Embolization2 reports
- TARGET M0035469300DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035474060DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035478200DEVICE, NEUROVASCULAR EMBOLIZATION1 death2 reports
- Target M0036155100DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035423580DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035474510DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035461230Device, Vascular, for Promoting Embolization2 reports
- TARGET M0035471130DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- TARGET M0035472040Device, Vascular, for Promoting Embolization2 reports
- TARGET M0035473100Device, Vascular, for Promoting Embolization2 reports
Recent TARGET adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Migration
It was reported that during an aneurysm embolization procedure, a first coil (Subject coil) was successfully placed in the aneurysm. A second coil was subsequently introduced but was determined not to be a suitable fit and was retracted into the microcatheter. During retraction of the second coil, the previously implanted first coil (subject coil) was unintentionally withdrawn from its implanted position within the aneurysm. The physician reported no resistance during the event. There was an approximate 10-minute procedural delay. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892963 ↗MalfunctionSep 18, 2026Premature Separation
It was initially reported that during introduction, the subject coil device became stuck within the microcatheter. Subsequent analysis of the returned coil device revealed that it had prematurely detached during use. The subject coil was replaced with a new device, and the procedure was completed successfully with no reported clinical consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813662 ↗MalfunctionSep 16, 2026Fracture
It was reported that the subject coil could not be advanced through the microcatheter. The subject coil was returned for analysis and it was discovered that the subject coil delivery wire was broken/fractured during use. The subject device was replaced, and 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 50782607 ↗MalfunctionSep 3, 2026Migration
It was reported that during procedure, the microcatheter was withdrawn at the conclusion of the procedure; however, the subject coil was inadvertently pulled out together with the microcatheter. 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 50577640 ↗MalfunctionAug 25, 2026Adverse Event Without Identified Device or Use Problem; Migration
It was reported that during an aneurysm embolization procedure, a first subject coil was successfully placed in the aneurysm. A second coil was subsequently introduced but was determined not to be a suitable fit and was retracted into the microcatheter. During retraction of the second coil, the first subject coil was unintentionally retracted from its implanted position. The physician reported no resistance during the event. Additional coil placement was subsequently attempted. The event resulted in an approximate 10-minute procedural delay. Additional coil placement was subsequently attempted, after which the aneurysm ruptured. The patient was transferred to neurosurgery for clipping. The physician reported that the patient was not expected to survive. No additional information is available.Update:Additional information received on 16-Sept-2026 confirmed that an aneurysm rupture was reported in association with the subject coil (Third coil). The aneurysm rupture occurred during the attempt to place the subject coil. The patient was transferred to neurosurgery for clipping. The physician reported that the patient was not expected to survive. The event resulted in an approximate 10-
Patient problems: No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm
MAUDE report 50434982 ↗InjuryAug 25, 2026Inadequacy of Device Shape and/or Size; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem
It was reported that during an aneurysm embolization procedure, a first coil was placed in the aneurysm. A second coil was determined not to be a good fit and was retracted into the microcatheter. During retraction, the first coil was also retracted. The physician reported that no resistance was encountered. A new subject coil was then attempted, after which the aneurysm ruptured. The consultant stated that the aneurysm rupture was caused by the coil. The event resulted in a 10-minute surgical delay. The patient was subsequently transferred to the neurosurgery department for clipping. The consultant stated that the patient would most likely not survive. No additional information available
Patient problems: No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm
MAUDE report 50434978 ↗MalfunctionAug 12, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226032 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during the procedure for a small approximately 2 mm blister Posterior Communicating Artery aneurysm and a wide neck Internal Carotid Artery (ICA)-T aneurysm, the physician decided to treat the smaller aneurysm. After unsuccessful attempts with two coils, the physician attempted to implant the subject coil. Even after detachment of the subject coil, it was perceived that the tip of the subject coil was still inside the microcatheter and not fully detached. Thus, a stent was deployed to cover both the aneurysms and also to tack the coil and microcatheter against the vessel wall. the physician then pulled the microcatheter leaving the subject coil detached and implanted inside the aneurysm. The subject device was replaced, and the procedure was completed successfully. There was a surgical delay of 15 min due to the reported event. No clinical consequences were reported to the patient due to this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102860 ↗MalfunctionJul 30, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086818 ↗MalfunctionJul 22, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25908401 ↗InjuryJun 30, 2026Fracture; Expulsion
IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DETACH THE SUBJECT COIL, BUT THE SUBJECT COIL FAILED TO DETACH. FORCEFUL TRACTION APPLIED TO SUBJECT COIL DELIVERY WIRE, RESULTED IN BREAKAGE AT THE DISTAL SEGMENT OF THE DELIVERY WIRE. THE DETACHED DISTAL SEGMENT COULD NOT BE RETRIEVED. FOLLOW-UP ANGIOGRAPHY REVEALED SUBJECT COIL PROTRUSION, AND A RESCUE STENT WAS PLACED TO MANAGE THIS COMPLICATION. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 25669783 ↗MalfunctionJun 30, 2026Fracture; Expulsion; Premature Separation
It was reported that during coronary artery fistula procedure, planned for coil embolization. After delivering the guiding catheter to the target position via the radial artery, the physician delivered the microcatheter to the fistula opening. A Stryker coil was delivered, positioned, and successfully detached. The physician then delivered an additional coil. After flushing, delivery was initiated with no resistance. After inserting, the physician was dissatisfied with the result and attempted to reposition the coil 3 times, still unsatisfactory. The physician then attempted to retrieve the subject coil but found it had already detached and could not be retrieved. Angiography confirmed the subject coil had not migrated. The physician then withdrew the delivery wire, and after taken out it was found a metal wire connected at tip of the delivery wire. The physician then used coils and a microcatheter of another brand to continue inserting until satisfied, then concluded the procedure. After the patient went back to ward, the nurse discovered a metal wire at the radial artery occlusion area (external the skin). Following angiography revealed a wire-like structure extending from corona
Patient problems: Foreign Body In Patient
MAUDE report 25669776 ↗MalfunctionJun 23, 2026Premature Separation
THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS FOUND DETACHED FROM THE SUBJECT COIL DELIVERY WIRE. 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 25589739 ↗MalfunctionJun 22, 2026Premature Separation
It was reported that the coil (subject device) was used in the medical procedure. However, the subject coil encountered resistance while advancing through the microcatheter and got detached prematurely. The procedure was reported to be completed successfully. No clinical consequences were reported to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25587935 ↗MalfunctionJun 22, 2026Premature Separation
IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE ADVANCING THROUGH THE MICROCATHETER AND GOT DETACHED PREMATURELY. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25587901 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
- InTouch5 models · 666 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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