RebarTMRecalls & reported problems across all models
Micro Therapeutics, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 126
- Deaths reported
- 2
- Injuries reported
- 6
- Recalls
- 0
We found 4 models of RebarTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2018 and Feb 3, 2026 — classified as 2 deaths, 6 injuries, 118 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (97 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 RebarTM problems
Device problems
- Physical Resistance/Sticking97
- Break13
- Material Deformation13
- Packaging Problem7
- Device Dislodged or Dislocated6
- Adverse Event Without Identified Device or Use Problem5
- Burst Container or Vessel5
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions111
- No Known Impact Or Consequence To Patient6
- Stenosis3
- Thrombosis/Thrombus3
- Intracranial Hemorrhage2
- Thromboembolism2
- Coma1
- Ischemia Stroke1
RebarTM models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RebarTM 105-5081-153Catheter, continuous flush2 deaths102 reports
- RebarTM 105-5082-145Catheter, continuous flush17 reports
- RebarTM 105-5081-130Catheter, continuous flush4 reports
- RebarTM 105-5083-153Catheter, continuous flush3 reports
Recent RebarTM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE AB ENCOUNTERED RESISTANCE AND THE TIP BECAME DAMAGED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY C6 SEGMENT. IT WAS NOTED THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION WAS APPROXIMATELY THREE HOURS. IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN ADVANCING THE DISTAL END OF THE SOLITAIRE AB STENT. AFTER SEVERAL ATTEMPTS AND WITHDRAWAL, IT WAS FOUND THAT THE TIP OF THE STENT WAS ¿ROUGH.¿ THE RESISTANCE WAS FELT DURING DELIVERY IN THE PROCEDURE. THE DISTAL SECTION OF THE CATHETER EXPERIENCED RESISTANCE. THE VESSEL WAS TORTUOUS. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS A MEDTRONIC PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO KINK OR DAMAGE OBSERVED ON THE CAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246999 ↗MalfunctionDec 9, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT SIGNIFICANT RESISTANCE AND STUCK WERE ENCOUNTERED WHILE ADVANCING THE SOLITAIRE STENT THROUGH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR ISCHEMIC STROKE THROMBUS REMOVAL LOCATED IN THE LEFT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS XXX AND VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 4, POST PROCEDURE SCORE WAS 1. BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE WAS 15, POST PROCEDURE SCORE WAS 4. BASELINE TICI SCORE WAS 0, POST PROCEDURE SCORE WAS 2B. IV TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. THERE WERE 0 PASSES WITH THE DEVICE. STROKE ONSET TO REPERFUSION TIME WAS 5 HOURS. IT WAS REPORTED THAT THE SURGEON PLANNED TO USE THE SAB-6-30 FOR THROMBECTOMY. THE LESION WAS LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. AFTER THE MICRO-GUIDEWIRE GUIDED THE MICROCATHETER IN PLACE, THE MICRO-GUIDEWIRE WAS WITHDRAWN, AND THE SAB-6-30 STENT WAS DELIVERED. SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS HALFWAY DELIVERED, WHICH THE SURGEON ATTRIB
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764592 ↗MalfunctionNov 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. IT IS UNCLEAR WHERE IN THE CATHETER THE RESISTANCE OCCURRED. HOWEVER, A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646079 ↗MalfunctionNov 24, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE SURGEON PLANNED TO USE A SOLITAIRE STENT FOR THROMBECTOMY. AFTER THE REBAR MICROCATHETER WAS IN PLACE, A 4-20 STENT WAS DELIVERED. HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN THE STENT REACHED THE MIDDLE OF THE MICROCATHETER, MAKING IT IMPOSSIBLE TO ADVANCE. RETRACTION OF THE STENT ALSO ENCOUNTERED RESISTANCE. TO ENSURE SAFETY, THE SURGEON REMOVED THE STENT AND MICROCATHETER AS A WHOLE. A GUIDEWIRE WAS ALSO FELT TO BE STUCK THROUGH THE MICROCATHETER, SUGGESTING POTENTIAL INTERNAL DAMAGE OF THE MICROCATHETER. A NEW MICROCATHETER WAS THEN USED INSTEAD TO COMPLETE THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR THROMBUS REMOVAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631354 ↗MalfunctionNov 17, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE, ACUTE EMBOLISM OF THE END OF THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS XXX AND VESSEL TORTUOSITY WAS SEVERE. THE PATIENT HAD A BASELINE MODIFIED RANKIN SCALE (MRS) SCORE OF 4 AND A NIH STROKE SCALE (NIHSS) SCORE OF14. PRIOR TO THE PROCEDURE, THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE WAS GRADE 1. DURING THE PROCEDURE, THE MRS IMPROVED TO 2, AND THE NIHSS SCORE DECREASED TO 2 POST-PROCEDURES. THE TICI SCORE POST-PROCEDURE WAS GRADE 3, INDICATING SUCCESSFUL REPERFUSION. INTRAVENOUS TPA WAS NOT CONTRAINDICATED. THE DEVICE WAS PASSED ONE TIME DURING THE PROCEDURE. THE STROKE ONSET TO REPERFUSION TIME WAS 2.5 HOURS. IT WAS REPORTED THAT DURING THROMBECTOMY WITH A STENT, THE OPERATOR ENCOUNTERED DIFFICULTIES IN DELIVERING THE SFR STENT DUE TO THE PATIENT'S TORTUOUS BLOOD VESSEL AND SIGNIFICANT RESISTANCE AT THE DISTAL SECTION OF THE REBAR DURING DELIVERING THE STENT. DESPITE SEVERAL ATTEMPTS, THE OPERATOR WAS UNABLE TO PUSH THE STENT OUT OF THE MICROCATHETER (REBAR18). AFTER REMOVAL OF THE STENT, THE STENT DELIVERY GUIDEWIRE WAS FOUND TO BE KINKE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575604 ↗MalfunctionNov 5, 2025Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS A LEFT MIDDLE CEREBRAL ARTERY M1. THE TORN CATHETER WAS NOT USED IN THE PATIENT. NO FRICTION OR RESISTANCE WAS ENCOUNTERED. RESISTANCE WAS IN THE DISTAL SECTION. A ZHONGTIAN DISTAL ACCESS CATHETER WAS USED. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THE CAUSE OF THE TEAR/LEAK WAS NOT DETERMINED. NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DEVICE PACKAGING WAS NOT DAMAGED ON DELIVERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480376 ↗MalfunctionOct 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE REBAR CATHETER MET RESISTANCE. IT WAS REPORTED THAT DURING A NEUROINTERVENTIONAL PROCEDURE ON A PATIENT, THE REBAR MICROCATHETER EXPERIENCED JAMMING AND COULD NOT BE USED NORMALLY. IT WAS IMMEDIATELY REPLACED WITH A NEW ONE. THE DEVICE AFFECTED THE DURATION OF THE SURGERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PROLONGED SURGERY WAS CAUSED BY THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE LESION WAS A RIGHT MIDDLE CEREBRAL ARTERY M1 SEGMENT OCCLUSION. THE EVENT OCCURRED DURING SURGERY AND THE BLOOD VESSEL WAS SEVERELY BENT. THE PROCEDURE WAS AN ACUTE ISCHEMIC STROKE, STENT THROMBECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348775 ↗MalfunctionSep 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE STENT MET RESISTANCE IN THE PROXIMAL END OF A REBAR CATHETER AND THE STENT WAS NOT MOVING FORWARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION STROKE. MCA VESSEL DIAMETER WAS 2.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23087559 ↗MalfunctionSep 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY OF THE SOLITAIRE FR THROMBECTOMY STENT, THE STENT COULD NOT PASS THROUGH THE MIDDLE OF THE REBAR CATHETER. ATTEMPTS WERE MADE TO RETRIEVE IT, HOWEVER, IT STILL FAILED TO PASS THROUGH. THE ENTIRE STENT SYSTEM AND CATHETER WERE REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING A THROMBECTOMY SURGERY FOR TREATMENT OF A ISCHEMIC STROKE IN THE INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7 MM. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. THE PROCEDURE INVOLVED ONE PASS WITH THE DEVICE. THE PATIENT'S BASELINE AND POST-THROMBECTOMY CONDITION (TICI, NIHSS ETC.) AND STROKE ONSET TO REPERFUSION TIME WAS UNKNOWN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038935 ↗MalfunctionSep 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT AFTER THE STENT WAS REMOVED AND HYDRATED, THERE WAS A LARGE RESISTANCE WHEN PUSHING THE CATHETER. WHEN THE STENT WAS PUSHED OUT OF THE CATHETER, IT WAS OBSERVED THAT IT WAS KINKED NEAR THE DEPLOYMENT POINT. CONCERNED THAT IT WOULD AFFECT THE DELIVERY OF THE STENT, IT WAS REPLACED WITH A NEW STENT AND THE OPERATION CONTINUED. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE AND KINK WAS NOT DETERMINED. RESISTANCE OCCURRED IN THE PROXIMAL SECTION OF THE CATHETER. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AND FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE. THERE WERE 0 PASSES WITH THE DEVICE. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031850 ↗MalfunctionAug 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS AN ANTERIOR CEREBRAL ARTERY OCCLUSION WITH MODERATE VESSEL TORTUOSITY. THE CAUSE OF THE RESISTANCE AND KINK WAS UNKNOWN. THE PATIENT¿S BASELINE (TICI, NIHSS, ETC.) AND POST-THROMBECTOMY CONDITION WERE ALSO UNKNOWN. RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22832066 ↗MalfunctionAug 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK OR DAMAGE TO THE SOLITAIRE WAS OBSERVED. NO KINK OR DAMAGE TO THE CATHETER WAS OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22727839 ↗MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING WHOLE BRAIN ANGIOGRAPHY AND THROMBECTOMY OPERATION FOR ISCHEMIC STROKE M2 SEGMENT OCCLUSION TREATMENT. THE SITE OF INTRACRANIAL VASCULAR OCCLUSION WAS DETERMINED BY ANGIOGRAPHY. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 40MIN IT WAS REPORTED THAT THE GUIDE SHEATH, NEUROVASCULAR GUIDEWIRE, THROMBUS ASPIRATION CATHETER, REBAR18 MICROCATHETER, AND INTRACRANIAL VASCULAR STENT SAB-6-30 WERE SELECTED. AFTER THE PREPARATION WORK WAS COMPLETED, THE REBAR 18 MICROCATHETER WAS SUCCESSFULLY PUT IN PLACE. THE SURGEON SELECTED THE INTRACRANIAL VASCULAR STENT SAB-6-30 AND MOISTENED IT IN VITRO. DURING THE DELIVERY PROCESS OF SLOWLY PUSHING THE STENT, IT WAS FOUND THAT THE RESISTANCE TO PUSHING THE STENT GRADUALLY INCREASED AT THE PROXIMAL SECTION OF THE CATHETER, AND FINALLY THE STENT COULD NOT BE PUSHED FURTHER. IT WAS FOUND THAT THE TAIL OF THE STENT WAS CLOGGED AT THE TAIL OF THE MICROCATHETER. THE SURGEON TRIED MANY TIMES BUT FAILED TO PUSH IT. TWO NEW REBAR18 MICROCATHETERS WERE USED INSTEAD FOR DELIVERY, BUT THEY COULD NOT BE PUSHED IN PLACE. BECAUSE THE PATIENT WAS AL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576412 ↗MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BASELINE NIHSS WAS 12 AND POST PROCEDURE TICI NIHSS HAD IMPROVED TO 3. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE PER THE IFU. THERE WAS NOT KINK/DAMAGE OBSERVED TO THE CATHETER(S) AFTER REMOVAL. ALL THE ATTEMPTED REBAR 18 MICROCATHETERS WERE FROM THE SAME MODEL/LOT. IT SHOULD BE NOTED THAT PER THE IFU, THE SAB-6-30 IS RECOMMENDED FOR USE WITH A CATHETER THAT HAS AN INNER DIAMETER OF 0.027 INCHES AND IS THEREFORE NOT COMPATIBLE/OFF LABEL USE WITH REBAR 18 CATHETER WHICH HAS AN INNER DIAMETER OF AS IT HAD A LABELED INNER DIAMETER OF 0.021 INCHES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576386 ↗MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING WHOLE BRAIN ANGIOGRAPHY AND THROMBECTOMY OPERATION FOR ISCHEMIC STROKE M2 SEGMENT OCCLUSION TREATMENT. THE SITE OF INTRACRANIAL VASCULAR OCCLUSION WAS DETERMINED BY ANGIOGRAPHY. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 40MIN IT WAS REPORTED THAT THE GUIDE SHEATH, NEUROVASCULAR GUIDEWIRE, THROMBUS ASPIRATION CATHETER, REBAR18 MICROCATHETER, AND INTRACRANIAL VASCULAR STENT SAB-6-30 WERE SELECTED. AFTER THE PREPARATION WORK WAS COMPLETED, THE REBAR 18 MICROCATHETER WAS SUCCESSFULLY PUT IN PLACE. THE SURGEON SELECTED THE INTRACRANIAL VASCULAR STENT SAB-6-30 AND MOISTENED IT IN VITRO. DURING THE DELIVERY PROCESS OF SLOWLY PUSHING THE STENT, IT WAS FOUND THAT THE RESISTANCE TO PUSHING THE STENT GRADUALLY INCREASED AT THE PROXIMAL SECTION OF THE CATHETER, AND FINALLY THE STENT COULD NOT BE PUSHED FURTHER. IT WAS FOUND THAT THE TAIL OF THE STENT WAS CLOGGED AT THE TAIL OF THE MICROCATHETER. THE SURGEON TRIED MANY TIMES BUT FAILED TO PUSH IT. TWO NEW REBAR18 MICROCATHETERS WERE USED INSTEAD FOR DELIVERY, BUT THEY COULD NOT BE PUSHED IN PLACE. BECAUSE THE PATIENT WAS AL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576380 ↗
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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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