MitraClip™ SGC0801Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 05415067050908), received between Jun 12, 2025 and Sep 29, 2026 — classified as 2 deaths, 35 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (67 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940222 ↗
• MalfunctionSep 29, 2026Crack; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934138 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 that the patient presented with grade 4 functional mitral regurgitation (MR) for a MitraClip procedure. During the procedure, a MitraClip was successfully implanted.Following device deployment, echocardiography identified a thrombus at the tip of the Steerable Guide Catheter (SGC). A guidewire was advanced through the SGC, and the SGC-dilator assembly was flushed until the thrombus was no longer evident. Heparin was administered. The SGC and dilator were subsequently advanced over the guidewire to facilitate implantation of a second clip.The patient remained hemodynamically stable throughout the procedure, and the thrombus was no longer visualized. The MR was reduced to grade <1 post procedure. There was no clinically significant delay reported.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50873519 ↗
• InjurySep 21, 2026Leak/Splash; Unstable; Air/Gas in Device

  It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (MR) and prolapsed posterior leaflet for a MitraClip procedure. During the procedure, a MitraClip was successfully implanted.Post deployment, the clip delivery system was retracted from the Steerable Guide Catheter(SGC). The stopcock attached to port on the hemostasis valve on the guide came unscrewed from the port. The port was sealed with finger to prevent loss of column and resealed the port using new three way stopcock. Aspiration was performed for removal of air. The procedure was continued with deployment of another MitraClip. The MR was reduced to grade 1 post procedure. There was no clinically significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844374 ↗
• InjurySep 18, 2026Leak/Splash; Difficult to Advance; Air/Gas in Device

  It was reported that a MitraClip procedure was performed to treat degenerative mitral regurgitation (MR) with a grade of 4 on a patient with a prolapsed posterior leaflet, thick leaflet, and pre-existing flail. A steerable guide catheter (SGC) and a MitraClip NTW were prepared per the instructions for use (IFU). A transseptal sheath was inserted, but difficulties advancing the transseptal sheath occurred. After transeptal access the groin was dilated with a 16F dilator with no difficulty. After obtaining transseptal access, the steerable guide catheter (SGC) was inserted. However, difficulty advancing the SGC occurred. Therefore, the SGC was removed, and the groin was dilated with a 22F dilator. The SGC was inserted again, but during advancement, resistance was encountered. The SGC was able to cross and was successfully advanced into position for the procedure. A MitraClip NTW was then inserted, and drips were slowed once the clip exited the guide. However, imaging revealed ¿bubbles¿ on the left side of the heart. After confirming drips where not fully opened on the device and anesthesia was not giving any fluids, it was discovered that there was air in the hemostatic valve of the

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels; Vascular Dissection

  MAUDE report 50820727 ↗
• MalfunctionSep 18, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820413 ↗
• MalfunctionSep 18, 2026Loose or Intermittent Connection

  It was reported that on (b)(6) 2026, a patient presented with grade 4 degenerative mitral regurgitation (MR), prolapsed posterior leaflet for a Mitraclip procedure. During the preparation, Stopcock on the dilator would not stay on the post. Second stopcock was opened and would not stay on the dilator port. Stopcock would twist off on its own despite tightening it onto the port. Device was replaced and continued the procedure. The final MR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818485 ↗
• InjurySep 16, 2026Leak/Splash; Air/Gas in Device

  It was reported on (b)(6)2026 that the patient presented with grade 4 mixed mitral regurgitation (MR) for a MitraClip procedure. During the procedure, a loss of column and air were observed in Steerable Guide Catheter(SGC) after dilator retraction and insertion of wire. Additional aspiration was performed for removal of air. Hypotension was noted. The SGC was removed from the anatomy.A replacement SGC was prepared and advanced inside anatomy. Again, a loss of column and air were observed in SGC after insertion of MitraClip NTW. Additional aspiration was performed for removal of air. The SGC was removed from the anatomy.A SGC replacement was utilized to complete the procedure with deployment of a MitraClip. The MR was reduced to grade 1 post procedure. There was no clinically significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793473 ↗
• InjurySep 16, 2026Leak/Splash; Air/Gas in Device

  It was reported on (b)(6) 2026 that the patient presented with grade 4 mixed mitral regurgitation (MR) for a MitraClip procedure. During the procedure, a loss of column and air were observed in Steerable Guide Catheter(SGC) after dilator retraction and insertion of wire. Additional aspiration was performed for removal of air. Hypotension was noted. The SGC was removed from the anatomy.A replacement SGC was prepared and advanced inside anatomy. Again, a loss of column and air were observed in SGC after insertion of MitraClip NTW. Additional aspiration was performed for removal of air. The SGC was removed from the anatomy.A SGC replacement was utilized to complete the procedure with deployment of a MitraClip. The MR was reduced to grade 1 post procedure. There was no clinically significant delay reported.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50793467 ↗
• MalfunctionSep 16, 2026Leak/Splash

  It was reported on (b)(6) 2026 that the patient presented with grade 4+ functional mitral regurgitation (MR) for a MitraClip procedure. During the preparation of Steerable Guide Catheter (SGC), loss of column was observed twice at the flush port after two separate de-airing processes following standard IFU instructions. Troubleshooting was performed and was unsuccessful. The SGC was replaced with another device to complete the procedure. The MR was reduced to grade <1 post procedure. There was no clinically significant delay or adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793250 ↗
• MalfunctionSep 10, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722671 ↗
• MalfunctionSep 9, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699668 ↗
• MalfunctionSep 4, 2026Difficult to Insert; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616726 ↗
• MalfunctionSep 4, 2026Difficult to Insert; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616533 ↗
• MalfunctionAug 31, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527017 ↗
• MalfunctionAug 27, 2026Difficult to Remove; Unintended Movement

  A MitraClip procedure was performed to treat degenerative mitral regurgitation (MR) with a grade of 4+ on a patient with prolapsed posterior leaflet and rotated heart. A steerable guide catheter (SGC) (60317A2077) and a MitraClip XTW clip delivery system (CDS) (60429A1098) were prepared for use and inserted. However, upon initial M down steering, the SGC tip and CDS moved in the wrong direction upon turning the knob. In the physician¿s opinion, the SGC and the CDS were miskeyed due to fluoroscopy deflection. Therefore, a decision was made to retract the CDS into the SGC. However, while retracting the CDS into the SGC, the clip frictional elements engaged with the soft tip of the SGC and became stuck. Troubleshooting was performed to remove the CDS from the SGC but was not successful. Therefore, a decision was made to remove the CDS and the SGC together as one system. Once the CDS and the SGC were safely in the inferior vena cava (IVC), the clip was able to be dislodged from the tip of the SGC. The entire system was then removed from the patient. A new SGC and a new clip were prepared for the procedure. Two clips were then implanted, reducing MR to a grade of 1. There were no advers

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484088 ↗
• MalfunctionAug 25, 2026Leak/Splash

  It was reported on (b)(6) 2026 that during preparation of the steerable guide catheter (SGC), when inserting the dilator into the hemostatic valve, a loss of fluid column occurred. Therefore, the SGC was not used and was replaced. There was no clinically significant delay in the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436268 ↗
• MalfunctionAug 24, 2026Failure to Advance; Material Split, Cut or Torn

  It was reported that on (b)(6) 2026, a patient presented with grade 4 degenerative mitral regurgitation (MR) for a MitraClip procedure. During the procedure, a steerable guide catheter (SGC) was attempted to be advanced within the patient whne excessive resistance was identified. Troubleshooting was performed and the device was removed from the patient. The device was examined and it was visualized that there was a split in the tip of the guide. A replacement SGC was selected and advanced within the patient. The procedure was performed successfully and an MitraClip was implanted. The procedure was discontinued, the final MR was reduced to grade 1. There were no adverse patient effects or clinically significant reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50407508 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6)2026 that the patient presented with grade 4 functional mitral regurgitation (MR) and a restricted posterior leaflet for a MitraClip procedure. During the procedure, an attempt was made to advance the Steerable Guide Catheter (SGC) across the septum. A thrombus was observed on the transseptal wire within the left atrium. At that time, the SGC dilator was positioned across the septum in close proximity to the thrombus. The dilator was carefully advanced just distal to the thrombus, aspiration was performed using a 50 cc syringe, heparin was administered and the SGC was subsequently withdrawn over the wire. In the interest of patient safety, a new SGC was used to successfully complete the procedure. The patient was reported to be in stable condition. The MR was reduced to grade 1 post procedure. There was no clinically significant delay reported.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50375348 ↗
• MalfunctionAug 18, 2026Crack; Leak/Splash

  It was reported that on (b)(6) 2026, a patient presented with grade 4-5 functional mitral regurgitation (MR) for a Mitraclip procedure. During the preparation, stopcock had an issue. Stopcock was taken off and there was chipped portion where it was connected. Leak was observed. Device was replaced and continued the procedure. The final MR was grade 1+. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307065 ↗
• MalfunctionAug 14, 2026Leak/Splash; Air/Gas in Device

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (MR) for a Mitraclip procedure. During the preparation, hemostatic valve of steerable guide catheter (SGC) would not hold the column. Air bubbles were observed. Device was replaced and continued the procedure. All steps were performed as per IFU. The final MR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254198 ↗
• MalfunctionAug 14, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253489 ↗
• MalfunctionAug 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246298 ↗
• InjuryAug 13, 2026Leak/Splash

  It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (MR) and a prolapsed posterior leaflet for a MitraClip procedure. Imaging was sub-optimal due to patient's complex anatomy. During the procedure, the Steerable Guide Catheter (SGC) was advanced into the anatomy. Subsequently, a loss of column was observed while attaching LAP monitoring line to the SGC. The patient then developed hypotension, tachycardia, and ST-segment elevation. Medication was used to treat hypotension.The procedure was terminated, and the SGC was removed from the anatomy. Evaluation subsequently determined that the guide catheter had traversed the right atrium, most likely at Waterston's groove. No intervention was required. The patient remained hemodynamically stable and was admitted to the intensive care unit (ICU) for close monitoring. Post-procedure, the MR remained grade 4+. There was no clinically significant delay reported.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Perforation; Tachycardia

  MAUDE report 50242000 ↗
• MalfunctionAug 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211164 ↗