SAPIEN M3 Dock Steerable Catheter 9880DDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00690103219760), received between Jan 20, 2026 and Jun 15, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Perivalvular Leak” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Perivalvular Leak; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THE VALVE WAS SUCCESSFULLY IMPLANTED WITH PVL (PARAVALVULAR LEAK) AT THE LC (LATERAL COMMISSURE) AND MC (MEDIAL COMMISSURE) WITH PERICARDIAL EFFUSION REQUIRING INTERVENTION. PERICARDIOCENTESIS WAS PERFORMED. A PLUG WAS PLACED AT THE LC. A SECOND PLUG WAS PLACED AT THE MC. THE PROCEDURE WAS COMPLETED AND MR (MITRAL REGURGITATION) GRADE WAS REDUCED FROM MODERATE/SEVERE TO NONE/TRACE. ADDITIONAL INFORMATION INDICATES THAT A PRE-EXISTING PERICARDIAL EFFUSION WAS NOTED DURING SCREENING AND INCREASED IN SIZE DURING THE PROCEDURE, REQUIRING PERICARDIOCENTESIS (~450 ML DRAINED). THERE WAS REPORTED LOADING DURING THE FIRST TURN, AND PER PHYSICIAN ASSESSMENT, A PERFORATION MAY HAVE OCCURRED DURING ENCIRCLING, ALTHOUGH THE EXACT TIMING AND LOCATION COULD NOT BE CONFIRMED DUE TO IMAGING LIMITATIONS.

  Patient problems: Cardiac Perforation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504802 ↗
• InjuryMay 29, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A SAPIEN M3 PROCEDURE IN THE MITRAL POSITION IN WHICH, DURING ENCIRCLING AROUND THE MEDIAL COMMISSURE, A POTENTIAL DEVICE-RELATED WALL PERFORATION WAS SUSPECTED; ALTHOUGH, THERE IS NO CONFIRMATION A PERFORATION OCCURRED AT THIS TIME. THE DOCK INTERACTED WITH THE SEPTUM, FOLLOWED BY A CONDUCTION SYSTEM DISTURBANCE RESULTING IN HEART BLOCK. THE PATIENT HAD A MAC SCORE GREATER THAN 9, AND DOCK TROUBLESHOOTING MAY HAVE CONTRIBUTED TO INTERACTION WITH THE SEPTUM. DURING THE PROCEDURE, THE MARKER BAND WAS OBSERVED NOT MOVING WITH THE DISTAL TIP, INDICATING POTENTIAL LOADING. DUE TO THE LARGE VOLUME OF MAC, THE PHYSICIAN SLIGHTLY UNSLEEVED THE DOCK. IN CONJUNCTION WITH ENCIRCLING MANEUVERS, THIS MAY HAVE RESULTED IN CONTACT WITH THE VENTRICULAR SEPTAL WALL AND CONTRIBUTED TO THE HEART BLOCK. INTERVENTION WAS REQUIRED, INCLUDING ADMINISTRATION OF ATROPINE AND EPINEPHRINE WITH SUBSEQUENT TEMPORARY PACING. A TEMPORARY PACEMAKER WAS ALREADY IN THE PATIENT. THE CLINICAL SPECIALIST WAS UNSURE WHETHER A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENTS MEDICAL HISTORY INCLUDED SAVR (23 MM) AND LAA CLIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH MITRAL REGURGIT

  Patient problems: Heart Block

  MAUDE report 25340569 ↗
• InjuryMay 22, 2026Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THE VALVE WAS SUCCESSFULLY IMPLANTED WITH PVL (PARAVALVULAR LEAK) AT THE LC (LATERAL COMMISSURE) REQUIRING INTERVENTION. TWO PLUGS WERE IMPLANTED. PVL GRADE WAS REDUCED FROM MODERATE/SEVERE TO NONE/TRACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260594 ↗
• InjuryMay 8, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN THE MITRAL POSITION DURING WHICH MILD INTRAPROCEDURAL PARAVALVULAR LEAK (PVL) WAS IDENTIFIED AT THE LATERAL P3 LOCATION. THE DECISION WAS MADE TO PLUG THE PVL. THE PROCEDURE WAS SUCCESSFUL, AND FOLLOWING PLUG PLACEMENT, THE PVL WAS TRACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126030 ↗
• InjuryApr 14, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN THE MITRAL POSITION IN WHICH MULTIPLE ATTEMPTS WERE MADE TO ENCIRCLE THE LEAFLETS. THREE TURNS WERE PUSHED OUT SEVERAL TIMES; HOWEVER, IT WAS NOT POSSIBLE TO CAPTURE ALL OF THE LEAFLETS. IT APPEARED THAT ALL LEAFLETS WERE CAPTURED EXCEPT FOR THE P3 LEAFLET. IN ATTEMPTS TO CAPTURE P3, THE MEDIAL COMMISSURE WAS RE-ACCESSED TO PROVIDE A BETTER TRAJECTORY, THE SLEEVE WAS EXTENDED TO ITS MAXIMUM, AND MULTIPLE MANEUVERS WERE PERFORMED TO RAISE THE DOCK/ENCIRCLING TURN MORE SUPERIORLY AND POSTERIORLY. DURING ONE SUCH ATTEMPT, THE DOCK TIP APPEARED ON TEE TO EXTEND OUTSIDE THE HEART BORDER IN THE POSTERIOR REGION. THE DOCK WAS PULLED BACK, AND A PERICARDIAL EFFUSION CHECK WAS PERFORMED, REVEALING A SIGNIFICANT EFFUSION. THE DSC WAS PROMPTLY REMOVED, THE GS WAS PULLED OUT OF THE FOSSA, HEPARIN WAS REVERSED, AND PERICARDIOCENTESIS WAS PERFORMED. A CHEST TUBE WAS PLACED, HOWEVER, BLOOD CONTINUED TO ACCUMULATE IN THE PERICARDIAL SAC, RESULTING IN HYPOTENSION. BLOOD WAS CONTINUOUSLY ASPIRATED FROM THE PERICARDIAL SPACE USING 60 CC SYRINGES. DURING THIS TIME, CT SURGERY WAS NOTIFIED AND MOBILIZED TO REPAIR THE PERFORATION. IT WAS NOTED THAT A

  Patient problems: Cardiac Perforation

  MAUDE report 24876119 ↗
• InjuryApr 6, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE ONE WEEK POST PROCEDURE THE PATIENT RETURNED TO THE HOSPITAL HAVING CONGESTIVE HEART FAILURE SYMPTOMS AND IT WAS FOUND THAT THERE WAS SEVERE PVL IN THE MEDICAL COMMISSURE. THE PATIENT WAS HOSPITALIZED AND ON POD 19 THE PVL WAS PLUGGED AND WAS RESOLVED. IMMEDIATELY POST PROCEDURE THERE WAS ONLY MILD PVL AND PATIENT WAS DOING WELL.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24791334 ↗
• InjuryMar 23, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THERE WAS SEVERE PVL AFTER VALVE DEPLOYMENT SECONDARY TO HEAVILY CALCIFIED ANNULUS. THE PVL WAS RESOLVED WITH A PLUG, BRINGING THE LEAK DOWN TO TRACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664013 ↗
• InjuryJan 30, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THERE WAS A P3 MILD PVL PRESENT THAT THE TEAM TRIED TO INTERROGATE WITH ECHO TO DETERMINE IF IT WAS FROM THE MC AND MAKING ITS WAY THROUGH THE PVL GUARD OR RATHER THE POSTERIOR LEAFLET P3 AREA PERFORATION THAT WAS A RESULT OF THE FAILED TEER PERFORMED ON (B)(6)2026. THEY WERE NOT ABLE TO DISCERN THE EXACT LOCATION OF THE PVL BUT STILL DECIDED TO PLUG IT. THE PLUG RESULTED IN NONE/TRACE PVL AT THE MC. THE PATIENT WAS DOING WELL POST PROCEDURE, AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225602 ↗
• InjuryJan 26, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THERE WAS SEVERE RESIDUAL PVL AT P3 POST PROCEDURE AND 2 PLUGS WERE INSERTED. PATIENT WAS STABLE POST PROCEDURE, AND PVL REMAINED AT SEVERE AT P3 POST PLUGGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180365 ↗
• InjuryJan 20, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THERE WAS MILD PVL POST DEPLOYMENT THAT REQUIRED PLUGGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121013 ↗
• InjuryJan 20, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THERE WAS A SEVERE PVL AFTER DEPLOYMENT, REQUIRING A PLUG. PVL WAS REDUCED TO MILD AFTER THE PLUG.

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120888 ↗
• InjuryJan 20, 2026Perivalvular Leak

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE THERE WERE 2 PVL'S INTRAPROCEDURAL THAT REQUIRED PLUGGING, ONE AT MC AND ONE AT P3. PVL AT MC WAS RESOLVED TO NONE, AND AT P3 IT WAS REDUCED TO MILD AFTER THE PLUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120618 ↗