PhenomTM 21 Catheter FG13160-0615-1S (UDI 00847536041844)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536041844), received between Nov 19, 2020 and Nov 25, 2025 — classified as 1 death, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS DISTAL EMBOLIZATION IN THE SAME TERRITORY DURING PROCEDURE, CAUSED BY FRAGMENTATION OF THE CLOTH DURING THROMBECTOMY. THE EVENT RESULTED IN HOSPITALIZATION AND HAD A CAUSAL RELATIONSHIP TO THE STENT AND PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EMBOLISM WAS IN THE CEREBRAL ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF THE CLOT FRAGMENTATION WAS THE MECHANICAL THROMBECTOMY. THE INITIAL LOCATION OF THE CLOT BEING TREATED WAS THE MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT. THE PATIENT VESSEL TORTUOSITY AND WHETHER THE DEVICE(S) WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WAS NOT COLLECTED IN THE CLINICAL TRIAL. NO ADDITIONAL ACTION WAS TAKEN IN ORDER TO RESOLVE THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT RECOVERED/RESOLVED THE SAME DAY ON (B)(6) 2020. THE EVENT WAS ASSESSED TO BE NOT RELATED TO THE STENT RETRIEVER. ADDITIONAL INFORMATION RECEIVED REPORTED THE CLINICAL EVENT COMMITTEE (CEC) ADJUDICATED ASSESSMENT OF THIS EVENT WITH THE CONCLUSION THE DISTAL EMBOLIZATION EVENT HAD A CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE AND COULD POSSIBLY BE RELATED TOTHE SOLITAIRE DEVICE AND/OR

  Patient problems: Thromboembolism

  MAUDE report 23653423 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THERE WAS EMBOLIZATION OF PART OF THE RETRIEVED CLOT DURING RETRIEVAL. THERE WAS OCCLUSION OF THE FRONTO LATERAL RIGHT M3 SEGMENT. NIHSS WAS 12. THE ISSUE WAS RESOLVED WITH SEQUELAE ON 2021-SEP-04. THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE ADVERSE EVENT WAS NOT RELATED TO THE UNDERLYING CONDITION OR DISEASE. THE ADVERSE EVENT WAS CASUALLY RELATED TO THE PROCEDURE AND DEVICE. THE SPONSOR ASSESSMENT REPORTED THE ADVERSE EVENT HAD A CASUAL RELATIONSHIP TO THE PROCEDURE AND WAS POSSIBLY RELATED TO THE REACT AND SOLITAIRE DEVICES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) CLOT, M2 IN THE RIGHT HEMISPHERE. THE PRE-PROCEDURE MTICI SCORE WAS 2B AND THE FINAL POST-PROCEDURE MTICI SCORE WAS 2B. ADDITIONAL INFORMATION WAS RECEIVED UPDATING THE PRE-PROCEDURE MTICI SCORE TO 0. IN ADDITION, IT WAS INDICATED THE EVENT WAS NOT RELATED TO THE RIPTIDE SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE EVENT AS DISTAL CEREBRAL ARTERY EMBOLISM. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BASELINE MRS WAS 1. ADDITIONAL INFORMATION WAS RECEIVED. THE SPONSOR ASSESSMENT WAS UPDATED INDICATING TH

  Patient problems: Embolism/Embolus

  MAUDE report 23650376 ↗
• DeathAug 3, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A SOLITAIRE AB STENT HAD RESISTANCE IN THE DISTAL SECTION OF THE PHENOM 21 CATHETER DURING RETRIEVAL. THE PATIENT CAME IN WITH WHAT WAS BELIEVED TO BE A BASILAR ISCHEMIC STROKE. DURING THE ANGIOGRAM IT WAS OBVIOUS THAT BOTH VERTEBRAL ARTERIES WERE SEVERELY STENOSED. THE SOLITAIRE AB WAS USED INSTEAD OF A SOLITAIRE X IN CASE THEY'D NEED TO LEAVE THE STENT IN SITU DUE TO THE STENOSIS. THE PHYSICIAN DID ONE PASS AND STRUGGLED TO RESHEATH THE STENT BUT MANAGED. HE THEN DEPLOYED THE STENT AGAIN IN A MORE PROXIMAL POSITION FOR A SECOND PASS BUT WAS UNABLE TO RESHEATH THE STENT WITH THE PHENOM 21 AND HAD TO DEPLOY. THE EVENT WAS THEN COMPLICATED BY SEVERE BILATERAL STENOSIS OF VERTEBRAL ARTERIES. PATIENT DETERIORATED IN HOSPITAL, HAS SEIZURES AND DIED IN HOSPITAL IN INTENSIVE CARE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS UNDERGOING BAILOUT STENTING TREATMENT OF AN ISCHEMIC STROKE. IT WAS A PROXIMAL/VERTEBROBASILAR OCCLUSION (BILATERAL). NIHSS BASELINE SCORE WAS 4. TICI BASELINE SCORE WAS 0. TICI POST PROCEDURE WAS 3. VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS TH

  Patient problems: Convulsion/Seizure; Stenosis

  MAUDE report 17452490 ↗
• InjuryAug 15, 2022Difficult to Advance; Device Dislodged or Dislocated; Physical Resistance/Sticking; Difficult to Advance; Device Dislodged or Dislocated; Physical Resistance/Sticking

  (B)(6) 2022 (B)(4) (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION THAT A SOLITAIRE 4X40 STENT HAD RESISTANCE IN THE PHENOM 21 CATHETER. THE CATHETER HAD DIFFICULTY NAVIGATING AND THE MARKER BAND DISLODGED. THE PHENOM 21 DID NOT NAVIGATE EASILY IN THE ARTERY. THE SOLITAIRE 6X40 HAD DIFFICULTIES TO ADVANCE IN THE PHENOM 21. IT WAS IMPOSSIBLE TO ADVANCE THE SOLITAIRE 6X40 IN THE PHENOM 21 BECAUSE OF TOO MUCH RESISTANCE AND FRICTION SO THE PHYSICIAN RETRIEVED IT AND DECIDED TO CHANGE OF DEVICE. THE PHYSICIAN SAW THE MARKER DETACHED IN THE ARTERY AND RETRIEVED IT THANKS TO ASPIRATION. THEN HE USED A MARKSMAN CATHETER AND A SOLITAIRE 4X40. THE CATHETER TIP WAS NOT SHAPED. THE MARKER BAND WAS REMOVED FROM THE PATIENT AND NO SURGICAL INTERVENTION WAS REQUIRED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING AIS TREATMENT. VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT IS DECEASED. THE CAUSE OF DEATH IS UNKNOWN BUT BELIEVED TO BE SEVERE AIS.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 15230244 ↗
• MalfunctionMar 2, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE CASE, WHILE NAVIGATING PHENOM21 THROUGH NAVIEN, THE PHENOM BROKE DISTALLY 8 CM FROM THE START OF CATHETER IN THE PROXIMAL SECTION. THERE WAS FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER AND THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED.  NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT MECHANICAL THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY WITH A DIAMETER OF 4.2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653873 ↗
• MalfunctionMar 1, 2022Difficult to Remove; Stretched; Device Dislodged or Dislocated; Difficult to Remove; Stretched; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA), THE PH YSICIAN WAS ATTEMPTING TO ASPIRATE THE CLOT. THE PHENOM 21 WAS BEING USED FOR GUIDE. THE CATHETERS WERE DELIVERED TO THE DESIRED LOCATION AND THE PHYSICIAN ATTEMPT TO TAKE THE PHENOM 21 AND GUIDEWIRE BACK BUT THE PHENOM CATHETER TIP WAS ENTRAPPED. FORCE WAS NEEDED AND THE THE CATHETER WAS STRETCHED; IT WAS NOTED THE PROXIMAL MARKER WAS IMPLANTED.  THERE WERE NO PATIENT SYMPTOMS OR OTHER COMPLICATIONS ASSOCIATED WITH THIS EVENT. VESSEL TORTUOSITY WAS SEVERE. THERE WAS NO VASOSPASM OBSERVED. ANCILLARY DEVICE: PENUMBRA 4MAX GUIDE CATHETER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13636618 ↗
• MalfunctionJun 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CLOT WAS LOCATED IN "VERY DISTAL ANATOMY." VESSEL TORTUOSITY WAS MODERATE. THE ANATOMICAL LOCATION OF THE DISLODGED MARKER WAS "VERY DISTAL." THERE WAS NO PROCEDURAL/POST-PROCEDURAL IMAGING (CT, ANGIO, ETC.) AVAILABLE. THERE WERE NO IMAGES OF THE DEVICE AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11947495 ↗
• MalfunctionJun 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CLOT WAS LOCATED IN "VERY DISTAL ANATOMY." VESSEL TORTUOSITY WAS MODERATE. THE ANATOMICAL LOCATION OF THE DISLODGED MARKER WAS "VERY DISTAL." THERE WAS NO PROCEDURAL/POST-PROCEDURAL IMAGING (CT,ANGIO, ETC.) AVAILABLE. THERE WERE NO IMAGES OF THE DEVICE AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11947408 ↗
• InjuryJan 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED PATIENT CONDITION, AND MEDICAL OR SURGICAL INTERVENTION, AND/OR OUTCOME WOULD NOT BE REPORTED DUE TO CONFIDENTIALITY/PRIVACY REASONS. THERE WAS NO KINK OR DAMAGE OBSERVED TO THE PUSHWIRE OF THE SOLITAIRE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11137336 ↗
• MalfunctionNov 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE X BECAME STUCK INSIDE THE PHENOM MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A MECHANICAL THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SOLITAIRE X BECAME STUCK INSIDE THE PHENOM MICROCATHETER, AND IT WAS TOO DIFFICULT TO NAVIGATE. THE RESISTANCE WAS IN THE DISTAL SEGMENT OF THE CATHETER, AND IT WAS DIFFICULT TO REMOVE THE SOLITAIRE. THERE WAS NO VASOSPASM EXPERIENCED, AND THE CATHETER WAS FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A REBAR MICROCATHETER AND A SOLITAIRE. THERE WAS NO KINK OR DAMAGE ON THE CATHETER OR ON THE PUSHWIRE OF THE SOLITAIRE. THE TIP OF THE SOLITAIRE SHEATH WAS NOT SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10869015 ↗