Guidestar™ Steerable Guiding Sheath D141101Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00885672009496), received between Nov 10, 2020 and Jun 30, 2023 — classified as 5 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).

1 other recall cover devices cleared under the same FDA submission (K140406); they may or may not involve this specific model.

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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Break; Break

  AT THE BEGINNING OF THE PROCEDURE WHEN INTRODUCING THE LASSOSTAR NAV INTO THE HS CATHETER IT FELT SOME RESISTANCE WHICH WAS RELIEVED BY MOVING THE INFLATION KNOB IN THE HANDLE. THEN IN THE MIDDLE OF THE PROCEDURE, AFTER 2 VEINS WERE ABLATED THE SHEATH STEERING MECHANISM BROKE AND IT WASN'T POSSIBLE TO CURVE IT ANYMORE. LASTLY WHEN REMOVING CATHETERS FROM THE PATIENT, THE LASSOSTAR BROKE AND CAME OUT WITHOUT THE "LASSO" WITH THE 10 ELECTRODES. IT WAS CONFIRMED WITH X-RAY THE ELECTRODES WHERE INSIDE THE HELIOSTAR CATHETER. THERE WAS A 10-MINUTE DELAY, WHILE REPLACING THE GUIDESTAR WITH A NEW ONE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241197 ↗
• MalfunctionMay 12, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT SHEATH COULD NOT FLUSH BECAUSE AIR SEEMED TO BE COMING FROM THE ACCESS VALVE. MANY BUBBLES WERE VISIBLE WHILE FLUSHING. WHEN INSERTING THE HELIOSTAR CATHETER INTO THE SHEATH AND THE SHEATH IS TO BE FLUSHED, IT WAS NOT POSSIBLE BECAUSE MANY BUBBLES WHERE SEEN AND THEY DIDN'T STOP, THEY SEEMED TO BE COMING IN FROM THE ENTRANCE VALVE OR THE HANDLE. TRIED TO "SEAL" THE HANDLE TO ASSURE THE SHEATH WAS BEING FLUSHED, HOWEVER THIS WASN'T POSSIBLE. THEN WE REPLACED AND THE NEW SHEATH HAD THE SAME ISSUE BUT WAS POSSIBLE TO "SEAL" WITH A SPONGE AND ALLOW THE ATRIAL PRESSURE FLUSH THE SHEATH ON ITS OWN. THERE WAS 10 MIN DELAY REPORTED. PROCEDURE COMPLETED SUCCESSFULLY AND NO PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920663 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT DURING AN AFIB PROCEDURE THE HANDLE WAS BROKEN ON GUIDESTAR. THIS WAS NOTICED ABOUT HALF WAY THROUGH THE PROCEDURE, AFTER ISOLATION OF LPVS. THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14937454 ↗
• MalfunctionJun 22, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS THAT BUBBLES WERE SEEN IN SHEATH TUBE. NEW SHEATH WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776757 ↗
• MalfunctionJun 13, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE DEVICE WAS INTRODUCING AIR. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14679134 ↗
• MalfunctionJun 7, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED BROKEN MEMBRANE INTRODUCING AIR. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626020 ↗
• MalfunctionMay 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SHEATH WAS BROKEN AND LEAKING. NEW SHEATH REQUIRED TO COMPLETE THE PROCEDURE. PROCEDURE COMPLETED SUCCESSFULLY AND THERE WAS 20 MIN DELAY REPORTED. THERE WAS NO ADVERSE PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473947 ↗
• MalfunctionApr 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOMETHING IS BROKEN OFF FROM THE SHEATH. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168741 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELIOSTAR EE - AFTER SHEATH EXCHANGE (SL1 FOR GUIDESTAR), ST ELEVATION WAS OBSERVED ON THE ECG, LEADING AFTER SOME MINUTES TO SEVERAL VF EPISODES. SYSTOLIC BLOOD PRESSURE DROPPED TO 3.5-4 AND A CORONAROGRAPHY WAS PERFORMED. IT SHOWED A POSSIBLE CORONARY SPASM IN THE DESCENDANT ANTERIOR PART OF THE LEFT CORONARY ARTERY. ALSO, THE PATIENT HAD AN ISCHEMIC EPISODE IN THE PAST THAT WAS VISIBLE IN THE CORONAROGRAPHY BUT HAD NOTHING TO DO WITH THIS ADVERSE EVENT AFTER 30-40 MINUTES, ECG CAME BACK TO NORMAL AND BP WAS STABILIZED. AF PROCEDURE WAS SUSPENDED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Ventricular Fibrillation

  MAUDE report 14141260 ↗
• MalfunctionApr 14, 2022Fluid/Blood Leak; Device Damaged by Another Device; Fluid/Blood Leak; Device Damaged by Another Device

  DURING AN AFIB - PAROXYSMA PROCEDURE, WHEN RETRACTING THE HELIOSTAR BALLOON INTO THE GUIDESTAR SHEATH, THE PHYSICIAN EXPERIENCED A LOT OF RESISTANCE AND COULDN'T GET THE HELIOSTAR BALLOON BACK WITHOUT APPLYING A LOT OF FORCE. THE PHYSICIAN RE-INFLATED AND THEN DEFLATED THE BALLOON (FOR 30 SECONDS) AND ATTEMPTED TO PULL THE BALLOON BACK INTO THE SHEATH. THE PHYSICIAN NOTICED THAT WHEN PULLING THE BALLOON BACK, THE SHEATH WOULD DEFLECT WITH THE FORCE APPLIED UNTIL IT FINALLY RELEASED AND THE TIP OF THE SHEATH WOULD SPRING. THIS OCCURRED ONLY ON THE RIGHT PULMONARY VEINS. AT THE END OF THE PROCEDURE, WHEN PULLING THE CATHETER OUT THE PHYSICIAN NOTICED A LOT OF LEAKING FROM THE VALVE (HUB). THERE WAS NO DELAY IN PROCEDURE AND IT WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115240 ↗
• MalfunctionApr 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  WHEN RETRACTING THE HELIOSTAR BALLOON TO THE GUIDESTAR SHEATH, THE PHYSICIAN EXPERIENCED A LOT OF RESISTANCE AND COULDN'T GET THE HELIOSTAR BALLOON BACK INTO THE SHEATH WITHOUT APPLYING A LOT OF FORCE. THE PHYSICIAN RE-INFLATED AND THEN DEFLATED THE BALLOON (FOR 30 SECONDS) AND ATTEMPTED TO PULL THE BALLOON BACK INTO THE SHEATH. THE PHYSICIAN NOTICED THAT WHEN PULLING THE BALLOON BACK, THE SHEATH WOULD DEFLECT WITH THE FORCE APPLIED UNTIL IT FINALLY RELEASED AND THE TIP OF THE SHEATH JUMPED AND WE HEARD A VERY LOUD SOUND (POP SOUND). THIS OCCURRED ONLY ON THE RIGHT PULMONARY VEINS. AT THE END OF THE PROCEDURE, WHEN PULLING THE CATHETER OUT THE PHYSICIAN NOTICED A LOT OF LEAKING FROM THE VALVE (HUB). THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078450 ↗
• MalfunctionApr 11, 2022Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT USER SAW BUBBLES IN THE PROXIMAL PART OF THE HANDLE AFTER THE INSERTION OF HELIOS BALLOON. THE USER REMOVED EVERYTHING AND REINSERTED THE BALLOON AND THEY NOTICED ST ELEVATION OVER ECG. IN 5 MIN ST SEGMENT RECOVERED. THERE WAS A WATER LEAKAGE REPORTED THROUGH THE SHEATH VALVE. PROCEDURE COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075330 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A HELIOSTAR EE PROCEDURE AFTER THE TRANSSEPTAL PUNCTURE, THE ABBOTT FIXED SHEATH (SL1) WAS EXCHANGED BY THE GUIDESTAR 13.5F. JUST AFTER INTRODUCING THE HELIOSTAR BALLOON, ST ELEVATION WAS NOTICED IN THE ECG, FOLLOWED BY APPROXIMATELY 6 EPISODES OF VENTRICULAR FIBRILLATION (10-15 BEATS EACH, MORE OR LESS). CORONARIOGRAPHY WAS PERFORMED, AIR EMBOLISM WAS SUSPECTED BUT NO EVIDENCE FOUND IN THE X-RAY IMAGING. AFTER 15 MINUTES THE ECG WAS NORMAL AGAIN, THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Non specific EKG/ECG Changes; Ventricular Fibrillation

  MAUDE report 14074880 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE LUNDERQUIST GUIDEWIRE AND SELECTIVE CATHETERS COULD BE INSERTED INTO THE DESTINO TWIST WITHOUT ANY PROBLEM. WHEN PULLING OUT THROUGH THE HEMOSTASIS VALVE, THE HUB DETACHED FROM THE HOUSING WITHOUT MUCH PRESSURE. THE PROCEDURE HAD TO BE INTERRUPTED AND A NEW IDENTICAL DESTINO TWIST WAS INSERTED. THE PATIENT IS DOING WELL, NO PATIENT ADVERSE EFFECT REPORTED. THERE WERE NO COMPLICATIONS, BUT THE PROCEDURE WAS DELAYED BY 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073952 ↗
• MalfunctionApr 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN REMOVING THE HELIOSTAR CATHETER FROM THE SHEATH THERE WAS SPRINKLING FROM THE SIDE OF THE VALVE OF THE SHEATH HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022746 ↗
• MalfunctionMar 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN EXTERNAL EVALUATION (EE) HELIOSTAR PROCEDURE, THE GUIDESTAR WAS PUSHED INTO THE LEFT ATRIUM (LA) VIA A STANDARD LONG GUIDEWIRE AS USUAL. WHEN TRYING TO RETRACT THE DILATOR THE SHEATH VALVE CAP CAME OFF AND STAYED CONNECTED TO THE INSIDE OF THE DILATOR PLASTIC TRANSPARENT TOP. A NEW SHEATH WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO MEDICAL INTERVENTION OR ADDITIONAL SURGERY WERE REPORTED. THERE WERE NO CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950924 ↗
• MalfunctionMar 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE BALLOON PREPARATION EVERYTHING WAS DONE PROPERLY IN THE PROPER ORDER (THE CABLE WAS CONNECTED FIRST IN A DRY AREA) TO AVOID ANY DAMAGE (WATER INSERTION) ON THE HANDLE CONNECTION (B)(4), BUT WHEN THE PHYSICIAN INFLATED THE BALLOON AND STARTED THE ABLATION SEVERAL IMPEDANCE AND TEMPERATURE ERROR MESSAGES APPEARED ON THE SCREEN. WE CHANGED THE CABLE TO TRY AND SOLVE THE ISSUE BUT WHEN WE DISCONNECTED THE CABLE A CERTAIN AMOUNT OF WATER EMPTIED FROM THE INSIDE OF THE HANDLE. DUE TO THE LACK OF MATERIAL WE SWITCHED THE PROCEDURE INTO A CONVENTIONAL ONE (USING STSF CATHETER). NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862378 ↗
• MalfunctionMar 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CATHETER WITHDRAWAL THE SHEATH WAS LEAKING DUE TO CRACK ON THE DISTAL PART OF THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13686294 ↗
• MalfunctionMar 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PULL WIRE BROKE DURING PROCEDURE. CHANGED TO A NEW SHEATH (NO DELAY IN SURGERY) AND PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONALLY, IT WAS REPORTED A SMALL AMOUNT OF FLUID WAS LEAKING AT THE END OF THE SCREW MECHANISM, WHERE THE DILATOR IS SCREWED IN. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684771 ↗
• MalfunctionMar 4, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT SMALL AIR BUBBLES IN IRRIGATION TUBING FROM SHEATH WAS VISIBLE. ASPIRATION WAS NEEDED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666158 ↗
• MalfunctionMar 2, 2022Air/Gas in Device; Air/Gas in Device

  DURING INSERTION OF HELIOSTAR INTO THE FIRST PART OF THE GUIDESTAR SHEATH AND THE FOLLOWING ASPIRATION ACCORDING TO IFU THERE WERE LOTS OF BUBBLES BEING ASPIRATED. TAPPING THE SHEATH, TO MAKE SURE THE BALLOON IS STRAIGHT IN THE VALVE AND WITH SEVERAL ATTEMPTS (AT LEAST 10) WE RETRIEVED THE BALLOON. WITHOUT BALLOON INSIDE THERE WERE NO AIR BUBBLES AND ASPIRATION WAS POSSIBLE AS DESIRED. A NEW SHEATH WAS TRIED AND ERROR REMAINED. BALLOON WAS SLOWLY PUSHED DEEPER INTO THE SHEATH AND THE SLOW ASPIRATION MADE IT POSSIBLE TO ASPIRATE WITH NO MORE AIR BUBBLES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652951 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A HELIOSTAR EE PROCEDURE THERE WAS A PERICARDIAL EFFUSION. DR. (B)(6) AS THE PERFORMING DOCTOR HAD FINISHED INSERTING THE GUIDESTAR, HELIOSTAR AND LASSOSTAR INTO THE LEFT ATRIUM IN ORDER TO START ABLATION WHEN THE PATIENT'S BLOOD PRESSURE DECREASED. ECHO PROVED THAT THERE WAS PERDICARDIAL EFFUSION THAT WAS MANAGED WELL BY THE TEAM AND WE COULD CONTINUE WITH THE PROCEDURE AS NORMALLY AFTER A NEW AND BETTER TRANSSEPTAL PUNCTURE. THE MATERIAL ALL PERFORMED WELL AND WE HAD A NEAR-PERFECT HELIOSTAR PROCEDURE AFTER THE EFFUSION (5 SHOTS IN TOTAL, SHORT PROCEDURE TIME). ALL DISPOSABLES WERE DISCARDED BECAUSE NO ISSUES WERE FOUND ON THEM. THE PROCEDURE TOOK ONE HOUR LONGER THAN EXPECTED BECAUSE OF THE PERICARDIAL EFFUSION PROBLEM BUT NO REMAINING ISSUES/PROBLEMS FOR THE PATIENT ARE TO BE FORESEEN IN PHYSICIAN'S OPINION.

  Patient problems: Pericardial Effusion

  MAUDE report 13652926 ↗
• MalfunctionFeb 24, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED ERROR, INTRODUCING AIR REPEATEDLY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13594011 ↗
• MalfunctionFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AFTER HELIOSTAR CATHETER INSERTION, THE PHYSICIAN SLOWLY ASPIRATED THE SHEATH WITH A SMALL SYRINGE, WHEN NO MORE BUBBLES WERE VISIBLE HE FLUSHED IT A BIT, WITHOUT APPLYING MUCH PRESSURE. WHEN DOING THIS, THERE WAS SPRINKLING FROM THE SIDE OF THE VALVE OF THE SHEATH HANDLE. THE PHYSICIAN ALSO REPORTED THAT THIS HAS BEEN A COMMON OCCURRENCE LATELY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498118 ↗
• MalfunctionFeb 3, 2022Fluid/Blood Leak; Mechanical Problem; Difficult to Remove; Difficult to Advance; Air/Gas in Device; Fluid/Blood Leak; Mechanical Problem; Difficult to Remove; Difficult to Advance; Air/Gas in Device

  IT WAS REPORTED THAT WHEN INSERTING THE HELIOSTAR INTO THE SHEATH AND THEN SLOWLY ASPIRATING, A LOT OF BUBBLES WERE VISIBLE COMING OUT OF THE GUIDESTAR SHEATH TUBING. THE PHYSICIAN USED A LARGE SYRINGE AND STRAIGHTENED THE HELIOSTAR SHAFT IN ORDER TO MINIMIZE ANY AIR COMING IN THROUGH THE VALVE BUT AIR BUBBLES WERE STILL SEEN. HE THEN PUSHED THE HELIOSTAR CATHETER A BIT FURTHER INTO THE SHEATH (2-3CM) AND NO MORE BUBBLES WERE SEEN AND WE WERE ABLE TO PROCEED WITH THE PROCEDURE. AFTER ABLATING THE RSPV AND WHEN TRYING TO CANULATE THE RIPV, THE PHYSICIAN PULLED BACK THE HELIOSTAR BALLOON INTO THE SHEATH BUT WASN'T ABLE TO DO SO. HE TRIED TO USE A BIT MORE FORCE IT BUT WITHOUT SUCCESS. THERE WAS NO DEFLECTION ON THE SHEATH OR THE HELIOSTAR CATHETER. HE THEN PUSHED THE HELIOSTAR OUT OF THE SHEATH, INFLATED AND PERFORMED ABLATION ON THE RIPV BUT WHEN HE TRIED AGAIN TO PULL IT BACK, THE CATHETER WAS STILL GETTING STUCK AT THE DISTAL END OF THE SHEATH. THE PHYSICIAN THEN DECIDED TO PULL THE ENTIRE SYSTEM OUT DUE TO THE RISK OF PERFORATION IF HE CONTINUED TO TRY TO FORCE THE HELIOSTAR BACK. WITH THE SHEATH AND THE HELIOSTAR OUT OF THE PATIENT, WE THEN TRIED TO DO THE SAME MANEUVERS REPEATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140406. One submission often covers many models, so check the product and lot details in each record.

• Z-0646-2022 · Dec 22, 2021 · Completed
  Destino Twist 14F (also branded as Guidestar 14F)