Velocity Delivery Microcatheter VEL160STR-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 00814548012629), received between Sep 30, 2015 and Sep 29, 2026 — classified as 13 injuries, 284 malfunctions.

The most frequently reported specific device problem is “Break” (145 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 297 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  The patient was undergoing a thrombectomy procedure in the M1 segment of the middle cerebral artery (MCA) using a Velocity Delivery Microcatheter (Velocity), a Penumbra System RED 72 Silver Reperfusion Catheter (RED72 Silver), and a stent retriever. The physician used the Velocity to deliver a stent retriever to the target location. While removing the Velocity, the proximal end fractured. It was reported that the fracture to the Velocity occurred outside of the patient. The physician removed the fractured Velocity from the patient by hand.A new Velocity was used with the stent retriever through the RED72 Silver. The physician then observed a fracture to the distal end of the Velocity under fluoroscopy. The Velocity was subsequently removed from the patient in its entirety.The procedure was completed using the stent retriever and RED72 Silver. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932822 ↗
• MalfunctionSep 17, 2026Fracture

  The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (MCA) using a Velocity Delivery Microcatheter (Velocity), a Penumbra System RED 72 Reperfusion Catheter (RED72), a Neuron MAX 6F 088 Long Sheath (Neuron Max), and a guidewire. It was reported that the patient's anatomy was tortuous. The Neuron Max was placed in the right internal carotid artery (ICA). While advancing the RED72 and the Velocity over the guidewire through the Neuron Max to the target location, resistance was encountered. The Velocity and guidewire were removed together. After removal, the physician observed damage to the distal end of the Velocity. While inspecting the Velocity, the Velocity was found to be fractured at the distal end. It was reported that the guidewire was still within the Velocity. No part of the Velocity remained in the patient. The physician completed the procedure with one pass using the RED72. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805204 ↗
• MalfunctionSep 15, 2026Fracture

  The patient was undergoing a thrombectomy procedure in the M1 segment of the middle cerebral artery (MCA) using a Velocity Delivery Microcatheter (Velocity), a Penumbra System RED 72 Silver Reperfusion Catheter (RED72 Silver), and a stent retriever. The physician used the Velocity to deliver the stent retriever to the target vessel and made one pass. While removing the Velocity from the patient, the physician experienced resistance. The physician removed the RED72 Silver, Velocity, and stent retriever together. After removal, the Velocity was noted to be fractured.It was noted that while removing the Velocity from the RED72 Silver on the back table, the RED72 Silver fractured. The procedure was completed with a new Velocity and new RED72 Silver. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776008 ↗
• MalfunctionSep 10, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712801 ↗
• MalfunctionSep 1, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550835 ↗
• MalfunctionAug 7, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177099 ↗
• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150526 ↗
• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150521 ↗
• MalfunctionJun 10, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA GUIDE SHEATH, AND A GUIDEWIRE. THE PHYSICIAN ADVANCED THE VELOCITY AND RED62 TOGETHER OVER THE GUIDEWIRE TO THE FACE OF THE CLOT. THE VELOCITY AND GUIDEWIRE WERE THEN RETRACTED FROM THE RED62 WHEN THE VELOCITY FRACTURED. THE PHYSICIAN MANUALLY RETRIEVED THE FRACTURED VELOCITY AND GUIDEWIRE TOGETHER BY HAND. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY AND A NEW ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459615 ↗
• MalfunctionJun 2, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE SPHENOPALATINE ARTERIES (SPA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A MIDWAY 43 DELIVERY CATHETER (MIDWAY 43). IT WAS REPORTED THAT HYDROPHILIC EMBOLIC AGENT WAS PLACED THROUGH THE VELOCITY. AFTER REMOVING THE MIDWAY 43 AND VELOCITY TOGETHER, THE PROXIMAL LENGTH OF THE VELOCITY WAS NOTED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25) AND THE SAME MIDWAY 43. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368058 ↗
• MalfunctionApr 3, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VENOUS SINUS USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER ADVANCING THE VELOCITY THROUGH THE GUIDE CATHETER TO THE CONTRALATERAL SIGMOID SINUS, THE VELOCITY WAS FRACTURED NEAR THE STRAIN RELIEF. WHILE REMOVING THE VELOCITY FROM THE PATIENT, THE VELOCITY WAS NOTICED TO BE FRACTURED AT THE DISTAL END. THE VELOCITY WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY, THE SAME GUIDE CATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. HOURS POST-PROCEDURE, THE HOSPITAL STAFF FRACTURED THE CATHETER IN MULTIPLE LOCATIONS WHILE DESCRIBING THE EVENT TO THE PENUMBRA SALES REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775238 ↗
• MalfunctionMar 26, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE FOR A STROKE USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY). IT WAS REPORTED THAT THE VELOCITY HAD FRACTURED APPROXIMATELY AT THE PROXIMAL END TO THE MIDSHAFT. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705634 ↗
• MalfunctionMar 26, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY). IT WAS REPORTED THAT THE VELOCITY HAD FRACTURED AT THE MIDSHAFT TO THE PROXIMAL END. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702059 ↗
• MalfunctionMar 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). AFTER COMPLETION OF THE PROCEDURE, WHILE RETRACTING THE VELOCITY THROUGH THE BMX96, THE PHYSICIAN HEARD A SOUND AND NOTICED UNDER FLUOROSCOPY THAT THE PROXIMAL END OF THE VELOCITY HAD FRACTURED WITHIN THE BMX96. THEREFORE, THE PHYSICIAN REMOVED THE VELOCITY AND BMX96 TOGETHER AS A SYSTEM. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591908 ↗
• MalfunctionMar 6, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE RED62 OVER THE VELOCITY UP AND OVER INTO THE TARGET LOCATION, THE PHYSICIAN OBSERVED THAT THE VELOCITY WAS FRACTURED AT THE MIDSHAFT UNDER FLUOROSCOPY. THE RED62 AND THE VELOCITY WERE REMOVED TOGETHER. THE VELOCITY WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER VELOCITY, THE SAME RED62, THE SAME BMX96, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533937 ↗
• MalfunctionJan 5, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), TWO NON-PENUMBRA CATHETERS, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PARENT CATHETER TO THE ICA. NEXT, A NON-PENUMBRA CATHETER, THE VELOCITY, AND THE GUIDEWIRE WERE ADVANCED INTO THE PARENT CATHETER. IT WAS NOTED THAT THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE ADVANCING THE GUIDEWIRE INTO THE VELOCITY. THE VELOCITY AND THE GUIDEWIRE WERE REMOVED TOGETHER. AFTER REMOVAL, THE VELOCITY WAS NOTICED TO BE FRACTURED AT THE MID-SHAFT. THE ENTIRE FRACTURED VELOCITY WAS REMOVED FROM THE PATIENT. THE VELOCITY WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE NON-PENUMBRA CATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969361 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE VELOCITY WAS ADVANCED TO THE TARGET LOCATION AS PART OF AN ASPIRATION SYSTEM. THE PHYSICIAN REMOVED THE VELOCITY AND NOTICED THE VELOCITY HAD FRACTURED. IT WAS REPORTED THAT THE ENTIRE FRACTURED VELOCITY WAS REMOVED, AND NO PART OF THE VELOCITY WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619092 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA ASPIRATION CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE VELOCITY THROUGH THE ASPIRATION CATHETER, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE VELOCITY WAS STUCK AND FRACTURED AT THE DISTAL END. THE PROXIMAL END OF THE VELOCITY WAS REMOVED. THE ASPIRATION CATHETER CONTAINING THE FRACTURED DISTAL END OF THE VELOCITY WAS ALSO REMOVED. NO FRAGMENT OF THE VELOCITY WAS LEFT BEHIND IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, THE SAME ASPIRATION CATHETER, THE SAME SHEATH, AND THE SAME GUIDEWIRE RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE OF 2C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375284 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN DAMAGED THE VELOCITY WITHIN THE GUIDE CATHETER. THEREFORE, THE VELOCITY WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645819 ↗
• MalfunctionJun 18, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA REPERFUSION SYSTEM, A NON-PENUMBRA DELIVERY CATHETER, AND A STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED TWO FAILED PASSES WITH THE REPERFUSION SYSTEM. ON THE THIRD ATTEMPT, THE PHYSICIAN USED A STENT RETRIEVER THROUGH THE VELOCITY. WHILE WITHDRAWING THE VELOCITY THROUGH THE DELIVERY CATHETER, THE VELOCITY FRACTURED. THE FRACTURED VELOCITY WAS REMOVED FROM THE PATIENT THROUGH THE REPERFUSION SYSTEM. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286364 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68). DURING THE PROCEDURE, WHILE ADVANCING THE VELOCITY OVER A GUIDEWIRE TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE DISTAL END OF THE VELOCITY WAS NOT RESPONDING TO THE MOVEMENT OF THE VELOCITY AT THE PROXIMAL END. THE VELOCITY HAD FRACTURED AT THE MIDSHAFT OVER THE GUIDEWIRE. THEREFORE, THE PHYSICIAN REMOVED THE FRACTURED VELOCITY AND GUIDEWIRE TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY AND THE SAME RED68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132570 ↗
• MalfunctionJun 2, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA STENT RETRIEVER, AND A GUIDEWIRE. THE PHYSICIAN ADVANCED THE STENT RETRIEVER TO THE TARGET LOCATION USING THE VELOCITY. THE VELOCITY WAS BEING RETRACTED TO DELIVER THE STENT RETRIEVER. UPON RETRACTION, THE VELOCITY WAS FOUND TO BE FRACTURED PROXIMALLY. THE CAT6 AND THE STENT RETRIEVER WERE REMOVED AS A SYSTEM ALONG WITH THE DISTAL VELOCITY SEGMENT. THE PROCEDURE WAS COMPLETED WITH A NEW VELOCITY AND A NEW NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128545 ↗
• MalfunctionMar 29, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA SHEATH, AND A STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RED62 IN THE VESSEL AND THEN ADVANCED THE VELOCITY THROUGH THE RED62. NEXT, A STENT RETRIEVER WAS ADVANCED THROUGH THE VELOCITY AND WAS DEPLOYED IN THE TARGET LOCATION. THEN, WHILE REMOVING THE VELOCITY OUT FROM THE RED62, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER SUCCESSFULLY REMOVING THE ENTIRE VELOCITY OUT FROM THE RED62, THE PHYSICIAN NOTICED THE MIDSHAFT OF THE VELOCITY WAS FRACTURED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE CLOT USING THE STENT RETRIEVER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728366 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE VELOCITY WITHIN THE RED68. WHILE ATTEMPTING TO ADVANCE AND RETRACT THE VELOCITY, THE PHYSICIAN NOTICED THAT THE VELOCITY WAS NOT RESPONDING AND DECIDED TO REMOVE THE VELOCITY. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE PROXIMAL LENGTH OF THE VELOCITY WAS FRACTURED AND THAT THE DISTAL LENGTH OF THE VELOCITY REMAINED WITHIN THE RED68. THEREFORE, THE RED68 CONTAINING THE FRACTURED SEGMENT OF THE VELOCITY WAS REMOVED FROM THE PATIENT AND THE FRACTURED SEGMENT OF THE VELOCITY WAS FLUSHED OUT OF THE RED68. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME RED68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638947 ↗
• MalfunctionMar 11, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED ONE PASS WITHOUT SUCCESS. NEXT, THE PHYSICIAN ADVANCED THE RED72 OVER THE VELOCITY AND GUIDEWIRE TO THE TARGET LOCATION. THE PHYSICIAN THEN REMOVED THE VELOCITY AND GUIDEWIRE TOGETHER. AFTER REMOVAL, THE VELOCITY WAS NOTICED TO BE FRACTURED IN TWO LOCATIONS. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME RED72. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21579638 ↗