SavvyWire X-SmallRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07540184030019), received between Feb 10, 2023 and Aug 31, 2026 — classified as 4 deaths, 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• DeathAug 31, 2026Material Deformation

  F3001: During the procedure, immediately after valvuloplasty, the SavvyWire was noted to be kinked. The procedure continued; however, following valve deployment, the patient's aortic pressure did not increase. A perforation of the ventricular wall was subsequently identified. Despite the measures taken, the patient died.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50524478 ↗
• InjuryDec 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLICATED VIV CASE USING SAVVY. SMALLER VENTRICLE WHERE RAVI REMINDED TECH TO KEEP EYE ON SAVVY WIRE IN VENTRICLE SINCE WIRE KEPT "COMING BACK". 26MM SAPIEN IN 26MM SAPIEN. 24MM TRUE BALLOON USED TO CONFIRM SAVVY WAS THROUGH CENTER OF VALVE. BAV PERFORMED WITH 24 TRUE. NEW 26 SAPIEN NEEDED SLIGHT BALLOON INFLATION TO NAVIGATE ACROSS EXISTING VALVE. EXTENDED PACING RUN AT 182BPM, 25MA, VOO NEEDED DURING SLOW DEPLOYMENT. POST VALVE PRESSURES WERE IN LOW 70'S. ANESTHESIA GAVE NEO PER RAVI REQUEST. AT THIS POINT RAVI NOTICED AN EFFUSION ON TEE. ANESTHESIA STATED IT WAS THERE BEFORE CASE. PRESSURE DID NOT IMPROVE AFTER MEDS. ANESTHESIA STATED EFFUSION LOOKED WORSE THAN INITIAL, PRESSURE NOW IN 60'S. CPR STARTED AND SURGEON IN ROOM PLACED PATIENT ON ECMO AND PERICARDIAL WINDOW PERFORMED. AFTER PATIENT STABILIZED STERNOTOMY PERFORMED AND SURGEON STATED BLEEDING WAS FROM LV. PATIENT TAKEN OF ECMO PRIOR TO LEAVING ROOM AND CURRENTLY RECOVERING.COMPLICATED VIV CASE USING SAVVY. SMALLER VENTRICLE WHERE RAVI REMINDED TECH TO KEEP EYE ON SAVVY WIRE IN VENTRICLE SINCE WIRE KEPT "COMING BACK". 26MM SAPIEN IN 26MM SAPIEN. 24MM TRUE BALLOON USED TO CONFIRM SAVVY WAS THROUGH CENTER OF VALVE. BAV P

  Patient problems: Pericardial Effusion

  MAUDE report 23906678 ↗
• DeathApr 4, 2025Capturing Problem; Insufficient Device Problem Information; Capturing Problem; Insufficient Device Problem Information

  EVENT AS DESCRIBED BY OPSENS SALES REPRESENTATIVE: PROCEDURE TYPE: TAVR. VALVE: EDWARDS SAPIEN 26MM. LOSS OF CAPTURE DURING DEPLOYMENT OF THE VALVE. THE EDWARDS VALVE EMBOLIZED. INTERVENTION WAS PERFORMED TO MOVE THE VALVE TO AN APPROPRIATE AREA IN THE AORTA. THE PATIENT DID NOT SURVIVE DESPITE THEIR EFFORTS. PACING RATE 180, OUTPUT OF 20MA. VOO WAS CONFIRMED. BEFORE THE DEPLOYMENT OF THE VALVE TEST PACING WAS CONDUCTED. PACING RATE OF 120, OUTPUT OF 20MA WALKED DOWN UNTIL LOSS OF CAPTURE AT 10MA.

  Patient problems: Cardiac Arrest

  MAUDE report 21778027 ↗
• InjuryJul 11, 2024Pacing Problem; Pacing Problem

  EVENT AS DESCRIBED BY OPSENS CLINICAL SPECIALIST: DURING DEPLOYMENT OF VALVE, UPON SAID FINAL INFLATION, THERE MAY HAVE BEEN LOSS OF CAPTURE ON WIRE, PATIENT THREW A PVC AND VALVE EMBOLIZED WITEVENT AS DESCRIBED BY OPSENS CLINICAL SPECIALIST: DURING DEPLOYMENT OF VALVE, UPON SAID FINAL INFLATION, THERE MAY HAVE BEEN LOSS OF CAPTURE ON WIRE, PATIENT THREW A PVC AND VALVE EMBOLIZED WITH A PRESSURE SPIKE AT 60 MMHG. UPON DISCUSSION, PHYSICIAN WAS UNSURE OF PVC THAT CAUSED EMBOLIZATION. FURTHER CONVERSATION THERE WAS SUSPICION OF INFLATION OF VALVE BALLOON WAS INCOMPLETE LEAVING 3-4 MORE CC'S OF CONTRAST TO COMPLETE DEPLOYMENT, ALLOWING A LOOSE VALVE. PATIENT HAD LARGE ANNULUS, BAV BALLOON ALSO SHUTTLED THROUGH VALVE. DOCTOR REPOSITIONED INTO APEX AND TESTED PACING; PRESSURE DROPPED AND HAD GOOD PACING CONTACT. PATIENT IS DOING OK.

  Patient problems: Aneurysm

  MAUDE report 19725389 ↗
• InjuryMay 23, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  EVENTS AS DESCRIBED BY OPSENS'S TRAINING MANAGER: THE SAVVYWIRE WAS INTRODUCED INTO THE LEFT VENTRICLE, A KINK OCCURRED AND CAUSED THE WIRE TO PERFORATE. THE LEFT VENTRICLE WALL. VALVE WAS SUCCESSFULLY DEPLOYED; PATIENT WAS PUT ON ECMO; THEN RECOVERED AND WAS TAKEN OFF SAME DAY.

  Patient problems: Pericardial Effusion

  MAUDE report 19385895 ↗
• MalfunctionApr 12, 2024Pacing Problem; Pacing Problem

  EVENT AS DESCRIBED BY OPSENS CLINICAL SPECIALIST: DURING DEPLOYMENT OF A 26MM VALVE USING SAVVYWIRE, CAPTURE WAS LOST NEAR END OF DEPLOYMENT AND VALVE EMBOLIZATION OCCURRED. DURING STAFF DEBRIEFING POST CASE THEY MENTIONED THAT SOMETIMES BAD THINGS CAN HAPPEN EVEN WHEN EVERYTHING IS DONE CORRECTLY, AND THEY DID NOT BELIEVE THAT SAVVY PLAYED A ROLE. PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097663 ↗
• InjuryJan 26, 2024Fracture; Fracture

  THE HOSPITAL INFORMED OPSENS THAT THE GUIDEWIRE'S COIL PEELED AWAY FROM THE COREWIRE DURING A TAVI PROCEDURE. A DISSECTION TOOK PLACE AT THE FEMORAL SITE WHEN GUIDEWIRE REMOVED FROM PATIENT. PATIENT IS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 18592421 ↗
• MalfunctionNov 29, 2023Pacing Problem; Pacing Problem

  EVENT AS DESCRIBED BY OPSENS TRAINING AND MEDICAL EDUCATION MANAGER : DURING DEPLOYMENT OF 23 MM SAPIEN 3 ULTRA, CAPTURE WAS LOST ON A FEW BEATS RESULTING IN EMBOLIZED SAPIEN VALVE. VALVE WAS PULLED TO THE ASCENDING AO AND ANOTHER VALVE WAS IMPLANTED UTILIZING THE SAME SAVVYWIRE FOR DEPLOYMENT AND RV PACING. CAPTURE WAS LOST DURING FINAL DEPLOYMENT DESPITE WIRE NOT¸ LOSING POSITION AND GROUND NEEDLE SECURE. SECOND VALVE WAS IMPLANTED WITHOUT ISSUES AND PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231516 ↗
• MalfunctionNov 21, 2023Material Separation; Material Separation

  OPSENS WAS INFORMED ON THE (B)(6) THAT SAVVYWIRE WAS INTRODUCED INTO THE LV THROUGH THE 6F PIGTAIL, AS THE PHYSICIAN WAS ADVANCING THE Z-MED BALLOON OVER THE SAVVYWIRE, IT WAS NOTICED UNDER THE FLURO THAT THE WIRE WAS BROKEN AT THE TIP. AFTER SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO SNARE THE WIRE OUT OF PATIENT'S BODY. TTE REVEALED THAT THE PATIENT HAD AN EFFUSION AND TAMPONADE. SUBSEQUENTLY, BLOOD TRANSFUSION WAS DONE, AND PATIENT STATUS WAS STABILISED. OPSENS LATER REACHED OUT TO THE PHYSICIAN FOR ADDITIONAL INFORMATION REGARDING THE CASE AND LEARNED THAT THE PATIENT EXPIRED A COUPLE OF DAYS AFTER THE PROCEDURE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 18181924 ↗
• InjuryJul 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT AS DESCRIBED BY OPSENS CLINICAL SPECIALIST: ON TUESDAY JUNE 13TH, THE PHYSICIAN WAS PERFORMING A TAVR WITH THE SAVVYWIRE (LOT OSW-0062 EXPIRATION 1/4/25). HE INTRODUCED THE SAVVYWIRE INTO THE VENTRICLE WITHOUT A PIGTAIL CATHETER; WHEN WE NOTICED THE WIRE WAS NOT IN THE APEX, WE ENCOURAGED HIM TO ADVANCE THE WIRE TO THE APEX. HE REPLIED, "THIS IS A DIFFERENT ANGIO VIEW", MEANING IN THIS VIEW ITS HARD TO TELL IF THE WIRE WAS IN THE APEX. THE MEDTRONIC VALVE WAS THEN INTRODUCED INTO THE BODY AND ADVANCED UP AND OVER THE AORTIC ARCH. NOW BEING IN THE RAO PROJECTION, THE SAVVYWIRE WAS STILL NOT IN THE APEX, BUT THE PHYSICIAN CONTINUED ADVANCING THE VALVE DELIVERY SYSTEM ACROSS THE VALVE. WHEN THE NOSE CONE CROSSED THE VALVE, THE TIP OF THE SAVVYWIRE STRAIGHTENED OUT ABRUPTLY AND STAYED THAT WAY UNTIL THE PHYSICIAN DID SOME WIRE MANIPULATIONS. AFTER THAT, THE WIRE DID GO BACK TO ITS PIGTAIL FORM BUT THERE WAS A NOTICEABLE KINK A COUPLE MILLIMETERS BELOW THE FIDELA SENSOR. THE PHYSICIAN THEN CONTINUED WITH THE PROCEDURE AND DEPLOYED THE VALVE. NO PACING WAS PERFORMED AT ALL BECAUSE THE PATIENT'S PRESSURE WAS SO LOW. THE DOCTOR THEN REMOVED THE DELIVERY SYSTEM AND WIRE BECAUSE TH

  Patient problems: Pericardial Effusion

  MAUDE report 17298657 ↗
• DeathJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT AS DESCRIBED BY OPSENS'S SALES REP: SAVVYWIRE WAS PROPERLY DEPLOYED INTO THE LV WITH NO COMPLICATIONS. AS THE EDWARDS TAVR VALVE WAS COMING THOUGH THE E SHEATH, THEY RUPTURED THE DESCENDING AORTA. THE DEVICE RUPTURED THE AORTA WHERE THE PATIENT HAD AN ANEURYSM IN THE AORTA. ONCE THE WIRE WAS REMOVED THERE WERE NO KINKS OR BENDS. THE WIRE DID NOT SHOW ANY DEFICIENCY. OPSENS SALES REP WAS INFORMED THE NEXT DAY THAT THE PATIENT HAS EXPIRED. OPSENS REACHED OUT TO THE PHYSICIAN, AND HE CONFIRMED THE EVENT DESCRIPTION.

  Patient problems: Vascular Dissection

  MAUDE report 17208870 ↗
• MalfunctionMar 3, 2023Pacing Problem; Pacing Problem

  EVENT OCCURRED IN SPAIN DURING THE SAFE-TAVI STUDY: THE SAVVYWIRE IN QUESTION WAS USED AS PER SAFE-TAVI PROTOCOL. AT THE STEP OF TAVI IMPLANTATION (BALLOON EXPANSION OF AN EDWARDS SAPIEN3), MOVEMENT OF THE WIRE WAS NOTICED AND LEFT VENTRICULAR CAPTURE WAS LOST. A STRONG HEART BEAT THEN PUSHED THE BALLOON OF THE VALVE, LEADING TO VALVE EMBOLIZATION IN THE AORTA. NOTE THAT ALL THE PREVIOUS STEPS WERE SUCCESSFUL; SUCCESSFUL PACING TEST AND SUCCESSFUL VALVULOPLASTY WITH PACING. HEMODYNAMIC VALUES (AORTIC AND VENTRICULAR PRESSURES) AND CURVES WERE CORRECTLY DISPLAYED BY THE OPSENS OPM3 SYSTEM. TAVI PROCEDURE WAS CONTINUED WITH THE IMPLANTATION OF A SECOND BALLOON-EXPANDABLE VALVE, FOR WHICH THE SAVVYWIRE WAS USED FOR SUPPORT AND POST-OP HEMODYNAMIC RECORDINGS ONLY. FOR THE SECOND VALVE IMPLANTATION, PACING WAS PERFORMED BY MEANS OF AN INDEPENDENT, RIGHT VENTRICULAR ELECTRO-CATHETER. OPSENS REACHED OUT TO THE PHYSICIANS RESPONSIBLE FOR THE OPERATION WHO CONFIRMED THAT THERE WAS NO PATIENT INJURY INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481214 ↗
• DeathFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAVVYWIRE WAS PROPERLY PLACED INTO LV WITH PIGTAIL CATHETER. AFTER VALVE WAS DEPLOYED ECHO TEE SHOWED AN INFUSION. ECHO PHYSICIAN UNSURE OF LOCATION OF INFUSION OR WHAT CAUSED THE INFUSION. PATIENT WAS TAPPED TO ADDRESS INFUSION. SUBSEQUENTLY, THE TEAM CONVERTED TO PERFORM OPEN HEART PROCEDURE. PATIENT LATER EXPIRED. CAUSE OF INFUSION IS UNKNOWN. PHYSICIAN DOES NOT FEEL THAT IT WAS OPSENS PRODUCT RELATED.

  Patient problems: Pericardial Effusion

  MAUDE report 16359022 ↗
• InjuryFeb 10, 2023Difficult to Advance; Difficult to Advance

  SAVVYWIRE WAS USED IN A DIFFICULT CASE THAT REQUIRED MULTIPLE EXCHANGES. A PERICARDIAL EFFUSION WAS NOTICED 1 HOUR AFTER THE CASE, BUT THE CAUSE OF THIS EFFUSION WAS NOT CLEARLY IDENTIFIED DURING THE CASE. WHEN INSERTING THE SAVVYWIRE IN THE LEFT VENTRICLE, PHYSICIAN ADVICE US THAT A LARGE FORCE WAS REQUIRED. IT WAS LATER IDENTIFIED THAT THIS SPECIFIC MODEL OF CATHETER USED IN CONJUNCTION WITH THE SAVVYWIRE TEND TO REQUIRE A LARGE FORCE TO DELIVER THE SAVVYWIRE. THE NARRATIVE OF THE PHYSICIAN IS AS FOLLOW: ''THE TIMING OF THE INJURY THAT CAUSED THE PERICARDIAL INJURY IS UNKNOWN, BUT I SUSPECT WAS WITHDRAWAL OF THE PIGTAIL SHEATH TO ALLOW THE SAVVY WIRE TO BE POSITIONED IN THE VENTRICLE. AS YOU KNOW, WE LATER IDENTIFIED THE PIGTAIL FROM A SPECIFIC MANUFACTURER TO BE ASSOCIATED WITH SIGNIFICANT RESISTANCE MOVING ACROSS THE WIRE SO NOW AVOID THAT PIGTAIL WHEN POSSIBLE. I DID NOT FEEL ANY ABNORMAL "POP" OR OTHER TACTILE SENSATION THAT WOULD HAVE CONCERNED ME FOR AN INJURY.'' THE PERICARDIAL EFFUSION WAS DRAINED, AND THE PATIENT FULLY RECOVERED FROM THIS INJURY. THE INCIDENT WAS INITIALLY REPORTED AMONG THE LIMITED MARKET RELEASE FORMS OF THE SAVVY WIRE US POST MARKET REGISTRY ON THE 12

  Patient problems: Pericardial Effusion

  MAUDE report 16359020 ↗