Guidestar Steerable Guiding SheathRecalls & reported problems across all models

We found 2 models of Guidestar Steerable Guiding Sheath by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2020 and Jan 10, 2025 — classified as 1 death, 27 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (32 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Guidestar Steerable Guiding Sheath recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 22, 2021Completed

   There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

   Z-0646-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported Guidestar Steerable Guiding Sheath problems

Guidestar Steerable Guiding Sheath models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Guidestar™ Steerable Guiding Sheath D141103

  INTRODUCER, CATHETER
  1 recall1 death60 reports
• Guidestar™ Steerable Guiding Sheath D141101

  INTRODUCER, CATHETER
  43 reports

Recent Guidestar Steerable Guiding Sheath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEMATOME PUNCTURE SITE. ADDITIONAL INFORMATION 08/JAN/2024 DURING ATRIAL FIBRILLATION PROCEDURE, HEMATOME PUNCTURE SITE. PATIENT IS RECOVERING, RESOLVING. DEVICE IS ASSOCIATED WITH SECURE STUDY. (B)(6), NAME OF CONTACT. A FOLLOW UP ACTIVITY WILL BE INITIATED FOR THE REST OF THE QUESTIONS. WE WILL NOTIFY IF ADDITIONAL INFORMATION IS RECEIVED. NOT KNOWN IF DEVICE WILL BE RETURNED FOR EVALUATION, CHECKING WITH SALES REPRESENTATIVE. BEING SUBMITTED FOR ADMINISTRATION PURPOSES 1(B)(4).

  Patient problems: Pseudoaneurysm

  MAUDE report 21123577 ↗
• DeathNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SERIOUSNESS CRITERIA. DEATH: YES. LIFE-THREATENING ILLNESS OR INJURY: NO. A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES ADMISSION DATE: (B)(6) 2024 DISCHARGE DATE: (B)(6) 2024 MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO CHRONIC DISEASE: NO FETAL DISTRESS, FETAL DEATH, A CONGENITAL ABNORMALITY, OR BIRTH DEFECT INCLUDING PHYSICAL OR MENTAL IMPAIRMENT: NO. 04/NOV/2024 ADDITIONAL INFORMATION: PATIENT (B)(6) WAS TREATED BY ABLATION PROCEDURE ON (B)(6) 2024, THERE WAS NO DELAY IN PROCEDURE, AND NO ADDITIONAL MEDICAL INTERVENTION DURING PROCEDURE WAS NOTED. PATIENT WAS DISCHARGED AFTER PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT'S HEALTH STATUS WAS NORMAL. THE INVESTIGATIONAL DEVICES (CABLE, CATHETER, GENERATOR, AND SHEATH) WERE USED ONLY ONCE. IN ADDITION TO THE INVESTIGATIONAL CATHETER, A MAPPING CATHETER WAS ALSO USED. THE DEVICE WAS USED AS PER PROTOCOL, AND NO DEVICE DEFICIENCY WAS REPORTED. AFTER NORMAL USE, SINCE THERE WAS NO DEVICE DEFICIENCY REPORTED, THE SHEATH WAS DESTROYED AT SIT

  Patient problems: Cardiac Arrest

  MAUDE report 20758894 ↗
• MalfunctionSep 3, 2024Break; Break

  THE CUSTOMER INITIALLY REPORTED THAT DURING AN AFIB PAROX PROCEDURE THE PHYSICIAN FELT AND HEARD THE BREAK OF THE GUIDESTAR. AFTER SOME MANIPULATIONS IN THE HEART, THE GUIDESTAR BROKE. THE GUIDESTAR WAS CHANGED, AND THE PROCEDURE WAS FINISHED. THERE WAS ONLY A 5-MINUTE DELAY TO CHANGE THE GUIDESTAR. ON (B)(6) 2024 THE CUSTOMER REPORTED THAT THE ABLATIONS HAD ALREADY BEEN CARRIED OUT BEFORE THE GUIDESTAR BROKE. IT BROKE WHEN THE DOCTOR WAS MOVING INTO ANOTHER VEIN. THE FAM WAS DONE COMPLETELY. IT WAS ALSO REPORTED THAT THE DEVICE BROKE DURING USE WITHIN THE CHAMBERS OF THE HEART (LEFT ATRIUM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127628 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BLEEDING IN THE RIGHT GROIN. PRODUCT NOT RETURNING. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19497947 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT DEVELOPED A HEMATOMA IN THE RIGHT GROIN SOMETIME DURING OR AFTER AN ATRIAL FIBRILLATION (AFIB) PROCEDURE. THE PATIENT RECOVERED AND ISSUE RESOLVED. PRODUCT NOT RETURNING AS THERE IS NO PRODUCT DEFECT REPORTED.

  Patient problems: Hematoma

  MAUDE report 19372422 ↗
• InjuryOct 24, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THE GUIDESTAR WAS FULL OF BUBBLES; THE HEMOSTATIC VALVE DID NOT WORK PROPERLY. THE PATIENT EXPERIENCED BUBBLES IN RIGHT CORONARY. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY; THEREFORE, A HEMODYNAMIC PROCEDURE WAS NECESSARY TO REMOVE BUBBLES. THIS RESULTED IN A PROCEDURE DELAY OF 45 MINUTES. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED.

  Patient problems: Air Embolism

  MAUDE report 17995749 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  PROCEDURE - PRE-CLINICAL STUDY - HELIOS PFA DVT STUDY. IT WAS REPORTED THAT WHEN THE SHEATH WAS IN THE LEFT ATRIUM AND A CATHETER WAS BEING ADVANCED INTO THE SHEATH, THE SIDE PORT OF THE SHEATH BROKE OFF AND CAUSED BLOOD TO LEAK BACK. THEY REPLACED THE SHEATH AND THE PROCEDURE CONTINUED. NO REPLACEMENT SHEATH WAS REQUESTED. DOCUMENTATION REQUESTED FOR THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844455 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED:: 1. DURING THE CASE, AFTER RF APPLICATION AROUND THE LIPV, CHANGE OF THE PATIENT EKG, TRANSLATING SIGNS OF HEART ATTACK OR CORONARY SPASMS (UNCERTAIN REASON) 2. STANDARDIZATION OF THE EKG AFTER 10 MINUTES. THE ABLATION WAS FINALIZED WITHOUT ANOTHER INCIDENT. 3. AROUND 1H 30 LATER, PATIENT PRESENTED STROKE SYMPTOMS. 4. NEUROLOGICAL SYMPTOMS HAVE DISAPPEARED AT THE END OF THE DAY. ADDITIONAL INFORMATION: DURING THE CASE, ALL DEVICES HAVE BEEN USED ACCORDING TO USAGE INSTRUCTIONS: ABLATION AT 15W DURING 45SEC FOR ANTERIOR PART AND 15SEC FOR THE POSTERIOR PART IN TOTAL, PATIENT RECEIVED 4 RF APPLICATION FOR A TOTAL OF 3MINUTES OF RADIOFREQUENCY. ACT MEASURED AT 365 DURING THE CASE. AN EXTERNAL SHOCK WAS PERFORMED AT THE END OF THE CASE TO RESTORE SINUS RHYTHM. FOLLOWING THE CASE, PATIENT HAD ADDITIONAL EXAM: CORONARY ANGIOGRAPHY WHICH APPEARED NORMAL CEREBRAL IRM: LESION WERE FOUND CONFIRMING THE STROKE DIAGNOSTIC. SUBMITTING FOR ADMINISTRATIVE PURPOSES - ADVERSE EVENT.

  Patient problems: Cardiac Arrest; Non specific EKG/ECG Changes; Stroke/CVA

  MAUDE report 17711481 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICES USED DURING THE CASE: - CARTO3 SYSTEM SN: (B)(6) / V7.2.40.250 - NGEN GENERATOR SN: (B)(6) - NGEN PUMP SN: (B)(6). THE CALLER CONFIRMED THAT NO OTHER BIOSENSE WEBSTER DEVICES HAVE BEEN USED. CATHETER USED DURING THE CASE: - HELIOS STAR BALLOON - GUIDES STAR - LASSO STAR PLEASE NOTE THAT ALL CATHETERS HAVE BEEN DISCARDED SO THE CALLER COULDN'T PROVIDE ANY LOT NUMBERS. THE BWI REPRESENTATIVE CONFIRMED THAT THEY DIDN'T HAVE ANY ISSUE ON THE SYSTEM, BUT IT WAS REPORTED THAT THE PATIENT HAD A PHRENIC NERVE PALSY DURING THE ABLATION OF THE RIGHT PULMONARY VEIN. THE PATIENT IS ALIVE. PROCEDURE HAS BEEN COMPLETED. NO DELAY. TYPE OF PROCEDURE: PULMONARY VEIN ISOLATION (PVI). NO FURTHER ACTION NEEDED; THE CALLER JUST WANTED TO REPORT THE ADVERSE EVENT.

  Patient problems: Nerve Damage

  MAUDE report 17434512 ↗
• MalfunctionAug 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED 08/11/2023: THE CUSTOMER STATED ONE OF THE ELECTRODES WHICH DELIVERS RADIOFREQUENCY WAS DETACHED FROM THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432480 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT HAS BLEEDING GROIN. THERE IS NO REPORTED PERFORMANCE ISSUE ASSOCIATED WITH THE GUIDESTAR. THE PATIENT IS A 72-YEAR-OLD MALE, THAT IS PART OF A POST-MARKET CLINICAL STUDY NAMED (B)(4) SECURE. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT STARTING BLEEDING. IT IS UNKNOWN IF ANY BLOOD WAS LOST, AND WHEN THE BLEEDING OCCURRED. THE BLEED WAS RESOLVED WITH AN INTERVENTION WITH COMPRESSION BANDAGE AND STERI-STRIPS. THE PATIENT'S OUTCOME WAS REPORTED AS "RECOVERED/RESOLVED." THERE WAS NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 AND DISCHARGED ON (B)(6) 2023. IT WAS REPORTED, IN THE OPINION OF THE INVESTIGATOR IN ACCORDANCE WITH THE LIST OF EXPECTED EVENTS IN THE INSTRUCTIONS FOR USE, THIS ADVERSE EVENT WAS EXPECTED AND, OR ANTICIPATED. CUSTOMER MADE MULTIPLE ATTEMPTS TO OBTAIN LOT NUMBER AND TO GET THE DEVICE BACK, BUT ATTEMPTS WERE NOT SUCCESSFUL.THE CUSTOMER REPORTED THE ROOT CAUSE OF REPORTING THIS EVENT APPROXIMATELY 5 MONTHS AFTER EVENT, WAS DUE TO HUMAN ERROR BY THE TEAM IN CHARGE OF SEN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17417438 ↗
• 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, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PVI PROCEDURE SHEATH STARTED LEAKING THROUGH VALVE. IT WAS REPLACED AND PROCEDURE CONTINUED. THERE WAS 10 MIN DELAY REPORTED. NO PATIENT SIDE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921136 ↗
• 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 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER PROVIDED ADDITIONAL EVENT INFORMATION FOR THE REPORTED HEMATOMA IN GROIN; THERE WAS NO INJURY, NO HOSPITALIZATION, AND NO ADVERSE PATIENT EFFECT. PATIENT OUTCOME STATES RECOVERED AND RESOLVED. ADDITIONALLY, IT WAS REPORTED THERE WAS NO PRODUCT PERFORMANCE ISSUE. THE DEVICE WILL NOT BE RETURNED AND CUSTOMER WAS NOT ABLE TO OBTAIN LOT NUMBER.

  Patient problems: Hematoma

  MAUDE report 16912736 ↗

Other Oscor Inc. products

• Introducer Kit for Impella11 models · 1,326 reports · 9 recalls
• SafeSheath II14 models · 146 reports
• Destino Twist Steerable Guiding Sheath19 models · 45 reports · 1 recall
• SafeSheath Ultra Lite3 models · 24 reports · 1 recall
• Occlutech Delivery Set III10 models · 39 reports
• TourGuide Steerable Sheath9 models · 37 reports
• DiRex Steerable Sheath7 models · 22 reports
• Lead Adaptor3 models · 20 reports