Target TetraRecalls & reported problems across all models
Stryker Corporation · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 0
We found 19 models of Target Tetra by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2023 and Sep 23, 2026 — classified as 34 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (47 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 Tetra problems
Device problems
- Premature Separation47
- Fracture26
- Migration15
- Adverse Event Without Identified Device or Use Problem14
- Component Misassembled3
- Expulsion2
- Device Contaminated During Manufacture or Shipping1
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- Foreign Body In Patient7
- Thrombosis/Thrombus5
- Hemorrhage/Blood Loss/Bleeding3
- Ruptured Aneurysm3
- Device Embedded In Tissue or Plaque2
- Embolism/Embolus2
- Insufficient Information2
Target Tetra models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Target Tetra TG5411530Device, Vascular, for Promoting Embolization17 reports
- Target Tetra TG5412045DEVICE, NEUROVASCULAR EMBOLIZATION9 reports
- Target Tetra TG5413080Device, Vascular, for Promoting Embolization9 reports
- Target Tetra TG5412025DEVICE, NEUROVASCULAR EMBOLIZATION8 reports
- Target Tetra TG5411520DEVICE, NEUROVASCULAR EMBOLIZATION8 reports
- Target Tetra TG5412560DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- Target Tetra TG5413060Device, Vascular, for Promoting Embolization6 reports
- Target Tetra TG5412035Device, Vascular, for Promoting Embolization5 reports
- Target Tetra TG5412060DEVICE, NEUROVASCULAR EMBOLIZATION5 reports
- Target Tetra TG5412545Device, Vascular, for Promoting Embolization5 reports
- Target Tetra TG5414010DEVICE, NEUROVASCULAR EMBOLIZATION5 reports
- Target Tetra TG5412535Device, Vascular, for Promoting Embolization4 reports
- Target Tetra TG5413010DEVICE, NEUROVASCULAR EMBOLIZATION4 reports
- Target Tetra TG5413045Device, Vascular, for Promoting Embolization3 reports
- Target Tetra TG5413560DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- Target Tetra TG5413580DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- Target Tetra TG5414510DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- Target Tetra TG5413510DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- Target Tetra TG5414080Device, Vascular, for Promoting Embolization1 report
Recent Target Tetra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026No Apparent Adverse Event
It was reported that when physician attempted to insert the subject coil into the microcatheter, the resistance was encountered at the hub. The physician withdrew the delivery wire and introducer sheath for inspection; a thrombus was observed within the introducer sheath. The subject device was replaced, and the procedure was completed successfully.
Patient problems: Thrombosis/Thrombus
MAUDE report 50867854 ↗MalfunctionSep 18, 2026Premature Separation
It was reported that the subject coil advanced through the microcatheter into the middle meningeal artery (MMA) but the subject coil would not deploy. However, The subject coil was returned for analysis and the device investigation revealed that the main coil prematurely detached/separated during use. There is no additional information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819212 ↗MalfunctionSep 9, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702706 ↗MalfunctionAug 27, 2026Premature Separation
It was reported that during coil embolization using a compatible-lumen microcatheter, the resistance was encountered while attempting to retrieve the subject coil. Upon withdrawal, the subject coil stretched and prematurely detached inside the microcatheter shaft. Consequently, the subject coil and microcatheter were retrieved together. The procedure was completed successfully using a replacement coil and microcatheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465998 ↗MalfunctionAug 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464492 ↗InjuryAug 17, 2026Premature Separation
It was reported that during procedure, the subject coil got prematurely detached in the microcatheter and the subject coil got retrieved out by using guidewire and it was found to be stretched. 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 50287865 ↗MalfunctionJul 21, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25895815 ↗MalfunctionJul 16, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841261 ↗InjuryJul 14, 2026Premature Separation
IT WAS REPORTED THAT DURING THE PROCEDURE LAST FEW CENTIMETERS OF THE SUBJECT COIL WAS DIFFICULT TO PLACE IN ANEURYSM AND WAS MANIPULATED QUITE A LOT. THE SUBJECT COIL DETACHED PREMATURELY WHILE IT WAS MANIPULATED TRYING TO GET INTO THE ANEURYSM. THE COIL WAS RETRIEVED WITH A RETRIEVER STENT. THERE WAS 1 HOUR OF SURGICAL DELAY DUE TO THE EVENT. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816772 ↗MalfunctionMay 21, 2026Premature Separation
IT WAS REPORTED THAT DURING A COILING PROCEDURE, THE COIL WAS PARTIALLY DEPLOYED BY THE PHYSICIAN, THE PHYSICIAN WANTED TO REDEPLOY THE SUBJECT COIL AS SOME LOOPS WERE COMING OUTSIDE. IN THE PROCESS THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER AND THERE WAS RESISTANCE IN THE MICROCATHETER. THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER AND IT GOT SELF-DETACHED WITHIN THE MICROCATHETER. 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 25247870 ↗MalfunctionMay 7, 2026Premature Separation
THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL 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 25113483 ↗MalfunctionMay 6, 2026Fracture
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 25097462 ↗MalfunctionApr 21, 2026Premature Separation
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THE SUBJECT DEVICE WAS REPORTED TO BE REMOVED FROM THE BODY AND REPLACED WITH ANOTHER SIZE. 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 24942520 ↗MalfunctionApr 14, 2026Migration
IT WAS REPORTED THAT DURING A PROCEDURE FOR M-SEGMENT BIFURCATION OF THE RIGHT MIDDLE CEREBRAL ARTERY, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SUBJECT COIL THROUGH THE MICROCATHETER, THE SUBJECT COIL ENCOUNTERED GREATER RESISTANCE COMPARED TO THE PREVIOUS TWO COILS. MOREOVER, THIS COIL CONSISTENTLY FAILED TO FILL THE ANEURYSM AND KEPT HERNIATING OUT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE SUBJECT COIL MIGRATED OUT OF THE ANEURYSM. 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 24868037 ↗MalfunctionMar 20, 2026Premature Separation
IT WAS REPORTED THAT THE SUBJECT COIL WAS DEPLOYED PREMATURELY INSIDE THE PATIENT. 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 24651559 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- 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
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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