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SafeSheath® II SS9Recalls & reported problems

Oscor Inc. · Hemostatic Tear-away Introducer System with Infusion Side Port, 9F · Class 2

Adverse event reports
21
Deaths reported
1
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30891492002259), received between Feb 3, 2017 and Aug 25, 2026 — classified as 1 death, 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (12 reports).

4 other recalls cover devices cleared under the same FDA submission (K122084); 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 3 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Too Rigid or Stiff12
  • Adverse Event Without Identified Device or Use Problem3
  • Break2
  • Aspiration Issue1
  • Fluid/Blood Leak1
  • Insufficient Device Problem Information1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • No Known Impact Or Consequence To Patient3
  • Vascular Dissection2
  • Aspiration/Inhalation1
  • Cardiomyopathy1
  • Insufficient Information1
  • Perforation of Vessels1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 25, 2026Material Too Rigid or Stiff

    Patient problems: Insufficient Information

    MAUDE report 50430788 ↗
  • MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

    WE HAVE ENCOUNTERED A CONSISTENT PROBLEM IN THE LAST WEEK WITH AN IDENTIFIED 9FR SAFESHEATH IN OUR EP LAB. THE VALVE IS NOT SEALING AND BLEEDING BACK ONCE UTILIZED AFTER SUBCLAVIAN VEIN ACCESS. NOTE, EVENT DATE IS UNKNOWN, USED ESTIMATED EVENT DATE OF 02/01/2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21619245 ↗
  • InjuryDec 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    ON (B)(6) 2024 IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE IMPLANT OF IMPLANTABLE PULSE GENERATOR SYSTEM PROCEDURE, THE FRAYING TIP OF THE SAFE SHEATH DILATOR RESULTED IN MALE PATIENT EXPERIENCING VENOUS DISSECTION. THE IMPLANT PROCEDURE ATTEMPTED WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. REQUESTING ADDITIONAL ANSWERS FROM SALES REPRESENTATIVE; INCLUDING IF DEVICE BE RETURNED FOR EVALUATION. ON (B)(6) 2025 PATIENT RECOVERED FROM THE DISSECTION. AT TIME OF REPORTED EVENT, IMPLANTER HAD TRIED BUT NOT SUCCEEDED, IN IMPLANTING A LEFT VENTRICULAR LEAD VIA THE CORONARY SINUS. THEY THEN TRIED TO PUT THE NEW SHEATH IN TO GAIN ACCESS FOR AN ADDITIONAL LEAD IN THE RIGHT VENTRICLE. NO PROCEDURE DELAY PRIOR TO OBSERVING DISSECTION. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED; PATIENT WAS MONITORED POST PROCEDURE WITH PLANS TO REIMPLANT AT A LATER DATE, WHEN ISSUE HAD RESOLVED. PATIENT'S CORONARY SINUS WAS TORTUOUS, BUT THE BRACHIOCEPHALIC VEIN WAS NOT AND HAD SEVERAL SS7/SS9 SHEATHS PLACED DOWN WITH NO OBSTRUCTION EARLIER IN THE CASE. IT IS UNKNOWN IF PATIENT HAVE ANY PRE-EXISTING CONDITIONS, NO FURTHER INFORMATION PROVIDED. WAS ASKED

    Patient problems: Vascular Dissection

    MAUDE report 21047004 ↗
  • MalfunctionNov 22, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER SHEATH RUBBER VALVE WAS NOT SPLITTING PROPERLY AND GETTING STUCK TO THE LEAD. MULTIPLE SHEATHS WERE ATTEMPTED, HOWEVER REGARDLESS OF SIZE THE SAME ISSUE OCCURRED. THE SHEATHS WERE ATTEMPTED, REMOVED NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20761930 ↗
  • MalfunctionNov 22, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER SHEATH RUBBER VALVE WAS NOT SPLITTING PROPERLY AND GETTING STUCK TO THE LEAD. MULTIPLE SHEATHS WERE ATTEMPTED, HOWEVER REGARDLESS OF SIZE THE SAME ISSUE OCCURRED. THE SHEATHS WERE ATTEMPTED, REMOVED NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR EVALUATION. ON (B)(6) 2024: THE CUSTOMER REPORTED; NO, NOT REPORTED TO THE FDA, DP20760, PLI KIT SS9 SAFESHEATH II 9FR 13CM, SS9. ON (B)(6) 2024: MINIMAL DELAY OF NO MORE THAN 2 MINUTES, A MOSQUITO WAS USED TO HELP SEPARATE THE SHEATH, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IMAGE RECEIVED BY THE SALES REP AS THEY WERE NOT PRESENT AT THE TIME OF THE EVENT. IT IS UNKNOWN WHICH LOT NUMBER IS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20757944 ↗
  • MalfunctionNov 15, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER SHEATH RUBBER VALVE WAS NOT SPLITTING PROPERLY AND GETTING STUCK TO THE LEAD. MULTIPLE SHEATHS WERE ATTEMPTED, HOWEVER REGARDLESS OF SIZE THE SAME ISSUE OCCURRED. THE SHEATHS WERE ATTEMPTED, REMOVED NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 30/OCT/2024: MOSQUITO SCISSORS WERE USED TO PULL THE RUBBER VALVE APART. THE IMPLANTABLE PULSE GENERATOR (IPG) PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20694227 ↗
  • MalfunctionOct 28, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    ALL SHEATHS FOUND TO HAVE THE SAME ISSUE. WHEN PEELING AWAY THE SHEATH AFTER LEAD PLACEMENT THE VALVE DOES NOT DETACH PROPERLY. THIS RESULTS IN THE OPERATOR HAVING TO CUT THE VALVE OFF WITH SCISSORS OR SCALPEL. THE RISK IS THAT THE LEAD IS DISLODGED, THIS COULD BE SERIOUS IF THE PATIENT IS DEPENDENT ON THE LEAD AFTER PLACEMENT. EXTERNAL PACING MAY BE NEEDED. THERE IS ALSO THE RISK OF NEEDING TO REPEAT THE PROCEDURE WITH NEW VENOUS ACCESS IF THE LEAD IS DAMAGED IN THE PROCESS OF REMOVING THE VALVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20545118 ↗
  • MalfunctionSep 5, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    09/11/2024: DEVICE IS STILL IN (B)(6), IT WILL TAKE SOME TIME TO RECEIVE THE DEVICE. AS SOON AS WE RECEIVED THE DEVICE WE WILL FORWARD IT. 09/16/2024: NO PATIENT HARM REPORTED. PROVIDED PATIENT IDENTIFIERS. PROCEDURE REPORTED AS NEW RV ICD LEAD IMPLANT/ INSERTION. MINOR PROCEDURE DELAY REPORTED. INTERVENTION REPORTED AS: THE SURGEON SIMPLY HAD TO USE SCISSORS TO CUT AWAY THE OFFENDING PORTION OF THE SHEATH THAT FAILED TO SPLIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20145077 ↗
  • MalfunctionApr 2, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    DURING IMPLANT FOR PACEMAKER (MODEL L111) WHEN THE SHEATH WAS CUT, THE WHITE RUBBER SEAL DOESN'T SLIP IN HALF, AND IT REMAINS ON THE LEAD. INSTEAD OF PEELING IN HALF, IT COMES OUT OF THE SHEATH. DR. JUST CUT IT AND WENT ON WITH THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT IMPACT REPORTED. HOSPITAL/REPRESENTATIVE STATED DEVICE WOULD BE SENT BACK BUT HAS NOT YET BEEN RECEIVED, CURRENT STATUS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19019201 ↗
  • MalfunctionJan 3, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

    PEEL AWAY SHEATH NOT WORKING PROPERLY. THE INNER PLASTIC PIECE UNDER THE FOAM IS NOT BREAK AWAY. THE STAFF I HAVING TO EITHER PULL HARD OR USING SCISSORS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18440823 ↗
  • MalfunctionDec 29, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

    SHEATH WOULD NOT PEEL ALL THE WAY DOWN. THERE WAS NO PATIENT HARM. DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18421913 ↗
  • MalfunctionNov 4, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

    THE EVENT OCCURRED DURING IMPLANT PROCEDURE OF AN ICD COBLAT DR MRI IS1 DF4. IT WAS REPORTED THAT SPLITTING DIFFICULTY WAS EXPERIENCED WITH BOTH A SAFESHEATH SS9 AND SS7 INTRODUCER SYSTEM, BOTH WERE NOT SPLITTING COMPLETELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE ISSUE WITH THE SS9 WAS NOT ORIGINALLY REPORTED ON THE MPXR-1086642. BASED UPON THE PHOTOS RECEIVED FROM THE CUSTOMER, IT WAS QUESTIONED IF THERE MIGHT HAVE BEEN AN ISSUE WITH A SS9. PER MANUFACTURERS REQUEST, CUSTOMER INITIATED A FOLLOW-UP WITH THEIR FIELD REPRESENTATIVE. ON 10/OCT/2023, THE REP CONFIRMED THE SAME ISSUE OCCURRED WITH BOTH AN SS9 AND SS7, SAME PATIENT, SAME PROCEDURE. THE ICD IMPLANT WAS SUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PATIENT HAS A MEDICAL HISTORY OF CARDIOMYOPATHY. THE SS9 WAS RETURNED FOR EVALUATION. REFERENCE 1035166-2023-00105.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18070491 ↗
  • MalfunctionOct 4, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT THE SAFESHEATH VALVE WOULD NOT SPLIT WHEN IT WAS PEELED. THE PHYSICIAN HAD TO CUT THE VALVE PART WITH SURGICAL SCISSORS. THIS ALSO HAPPENED WITH A SECOND ONE. THERE WAS NO PATIENT INVOLVEMENT IN THE CASE. CUSTOMER DISCARDED PRODUCT. RELATED CASE: 1035166-2023-00102 - (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17871270 ↗
  • InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, HIGH/UNDEFINED PACING IMPEDANCE AND SHORT V-V INTERVALS. DURING THE LEAD EXTRACTION PROCEDURE, THE PHYSICIAN EXPERIENCED PROBLEMS PLACING THE GUIDEWIRE INTO THE VESSEL DUE TO STRONG INTERGROWTH OF THE RV LEAD, IN ADDITION TO THE STENOSIS OF THE VESSEL. AFTER CONTRAST WAS USED, DISSECTION OF THE VESSEL WAS OBSERVED. THE LEAD AND GUIDEWIRE WERE REMOVED, AND THE PHYSICIAN CHOSE TO PLACE A NEW ICD SYSTEM ON THE PATIENT'S RIGHT SIDE. NO INTERVENTIONS WERE NEEDED AS A RESULT OF THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CUSTOMER DISCARDED THE PRODUCT. SUBMISSION FOR ADMINISTRATIVE PURPOSES USER FACILITY SUBMISSION NUMBER: 2182208-2023-00530.

    Patient problems: Vascular Dissection

    MAUDE report 17661509 ↗
  • DeathMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THERE WERE DIFFICULTIES IN USING THE FIRST INTRODUCER (13CM) DUE TO PATIENT ANATOMY. A DIFFERENT LONGER INTRODUCER WAS USED (23CM) AND ABLE TO PASS THE SUBCLAVIAN ANGLE. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE IMPLANT THE PATIENT HAD SYMPTOMS AND WAS TAKEN TO CARDIAC SURGERY WHERE A SUBCLAVIAN VEIN LACERATION WAS DISCOVERED. THE LACERATION WAS STITCHED UP. THE PATIENT DIED FOLLOWING THE PROCEDURE. THE DEVICE WAS DISCARDED. PATIENT DEATH WAS ON (B)(6) 2023. CAUSE OF THE PATIENT DEATH IS UNKNOWN. OTHER EVENT RELATED TO THE ISSUE REPORTED: 1035166-2023-00049 ADDRESSES THE 23CM INTRODUCER (SAME PATIENT).

    Patient problems: Perforation of Vessels

    MAUDE report 16855063 ↗
  • MalfunctionAug 10, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT THE INTRODUCER DID NOT PEEL COMPLETELY. PHYSICIAN HAD TO USE A SCALPEL TO REMOVE PART THAT WASN'T PEELED. THE PATIENT A 75 YEAR OLD FEMALE WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15198510 ↗
  • InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE DOCTOR PUT THE FIRST 6935M (55CM) LEAD IN AND THEN AT THE END OF THE CASE DECIDED TO REPLACE THAT LEAD WITH A LONGER 6935M (62CM) LEAD. DOING THIS CREATED A SECOND INSERTION SITE IN THE VEIN THAT HE DID NOT CLOSE WITH A SUTURE WHEN HE REMOVED THE 55CM LEAD. THIS CAUSED A CONTINUOUS OOZE COMPLICATION, AS APPARENTLY THE PATIENT WAS ON BLOOD THINNERS. A VASCULAR SURGEON CAME IN TO HELP. ONCE HE CLEARED THE FIELD WITH SUCTION, HE STATED HE COULD CLEARLY SEE IT WAS IN FACT COMING FROM THE REMOVAL SITE OF THE 55CM LEAD. ONCE THE OOZE WAS BROUGHT UNDER CONTROL THE POCKET WAS CLOSED AS NORMAL (OPERATION WAS EXTENDED BY APPROXIMATELY BY 1 HOUR, 30 MINS). THE SAFESHEATH WAS DISCARDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12151221 ↗
  • InjuryAug 17, 2018Break; Break

    THE CUSTOMER REPORTED: ITEM NUMBER AND LOT# SS6 LOT# DP05539 AND SS9 LOT NUMBER DP05457. WAS THERE ANY PATIENT INJURY? NO WAS ABLE TO RETRIEVE PORTION OF SHEATH THAT BROKE OFF IN PATIENT. DO YOU HAVE A SAMPLE OF THE DEFECTIVE PRODUCT TO SEND BACK? YES I PULLED 28 6FR SHEATHS AND 3 9FR SHEATHS OFF THE SHELF WITH THE SAME LOT NUMBER AS THOSE THAT WERE DEFECTIVE. EVENT DATE (B)(6) 2017. HOSPITAL/FACILITY NAME AND ADDRESS. (B)(6). EVENT DESCRIPTION -CALL TO DISCUSS IF YOU NEED CLARIFICATION. PERFORMING MD DESCRIBES EVENT AS IF THE SHEATH IS SCORED WHERE IT IS SUPPOSED TO SPLIT AND IT IS INCOMPLETE RESULTING IN THE SHEATH BREAKING. IT IS SNAPPED, PULLED APART AND BREAKS-THEN STRETCHES AND PULLS APART SOME MORE AND BREAKS RESULTING IN SEVERAL PULLS TO REMOVE WHAT SHOULD BE ONE SMOOTH PULL AND PROCESS. THIS HAS HAPPENED MULTIPLE TIMES AND WE WILL SAVE PACKAGING IN THE FUTURE. THIS WAS THE FIRST TIME THAT A PIECE BROKE OFF IN THE PATIENT THAT REQUIRED RETRIEVAL. ADDITIONAL INFORMATION 7/24/2017: IT WAS ONLY THE 9FR THAT REQUIRED RETRIEVAL. IT WAS THE SHEATH SHAFT THAT WAS "RAGGED" AND NOT PEELING PROPERLY. THE SHEATH SHAFT WAS MANUALLY CUT AND REMOVED USING INSTRUMENTS FROM THE DEVICE TRAY

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7794850 ↗
  • InjuryApr 10, 2018Break; Break

    IT WAS REPORTED THAT DURING INSERTION OF THE SAFESHEATH, AS PART OF A PACEMAKER IMPLANT, PART OF THE WIRE BROKE OFF AND LODGED IN THE HEART. IT WAS CLARIFIED THAT THE WIRE MENTIONED WAS THE WIRE THAT COMES WITH THE SAFESHEATH. AN INTERVENTIONAL RADIOLOGIST WAS CALLED TO REMOVE THE WIRE USING A LASSO DEVICE. WITH SOME EFFORT, THE WIRE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS ABORTED AT THIS STAGE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT NOT ANY EXTENDED HOSPITAL STAY. NO FURTHER PATIENT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE INCIDENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7411259 ↗
  • MalfunctionMar 9, 2018Leak/Splash; Leak/Splash

    DURING INSERTING THE SHEATH IN THE VASCULAR SYSTEM AND WHEN PULLING THE DILATOR OUT OF THE INSERTED SHEATH A LEAK AT THE ENTRANCE TO THE LOCK IN THE AREA OF THE SEALING RING WAS NOTICED. THE SHEATH ALREADY DREW AIR AT THIS POINT, BEFORE THE WINGS BEING USED FOR PEELING. QUESTION: WHERE IS THE LEAK IN THE SEALING RING? DID THE EVENT OCCUR DURING SURGERY? YES. WAS THE PATIENT SUBJECTED TO PROCEDURES WHICH MIGHT HAVE DAMAGED THE DEVICE? YES. DID THE EVENT CAUSE AN ADVERSE CHANGE IN THE PATIENT'S CONDITION? NO.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7326895 ↗
  • MalfunctionFeb 3, 2017Aspiration Issue; Aspiration Issue

    IT WAS REPORTED THAT DURING IMPLANT, THE SHEATH WAS POSITIONED IN THE LEFT SUBCLAVIAN VEIN. THE PHYSICIAN OBSERVED AIR BUBBLES IN THE FLUSH LINE AND SYRINGE WHEN ASPIRATING FOLLOWING SHEATH PLACEMENT. IT WAS NOTED THAT WITHDRAWING THE SHEATH APPROXIMATELY ONE CENTIMETER PREVENTED THIS DURING ASPIRATION. ANOTHER SHEATH WAS ATTEMPTED, HOWEVER AIR BUBBLES WERE AGAIN OBSERVED DURING ASPIRATION. A NEW SHEATH WAS USED TO COMPLETE IMPLANTATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PATIENT HAS HISTORY OF DILATED CARDIOMYOPATHY. NO CLINICAL ACTIONS REQUIRED TO THE PATIENT DUE TO THIS EVENT. PATIENT UNDER PLANNED GENERAL ANAESTHETIC DURING PROCEDURE. ANAESTHETIST HAPPY WITH VENTILATION DURING THIS EVENT. NEW INFORMATION RECEIVED MARCH 31, 2016: COULD YOU PLEASE PROVIDE THE FOLLOWING INFORMATION: DID THE SURGEON FLUSH THE LINE TO REMOVE ALL AIR PRIOR TO USE OF THE DEVICE? YES, THIS IS DONE WITH EVERY SHEATH (BOTH HAEMOSTATIC AND NON-HAEMOSTATIC). IS IT KNOWN IF THE 3-WAY STOP COCK WAS NOT IN THE CORRECT (CLOSED) POSITION WHEN THE SURGEON OBSERVED AIR BUBBLES IN THE FLUSH LINE? IMPLANTING PHYSICIAN CONFIRMED THE 3-WAY STOPCOCK WAS IN THE CORRECT POSITION AS SO

    Patient problems: Aspiration/Inhalation; Cardiomyopathy

    MAUDE report 6301921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

  • Z-2680-2026 · Jun 10, 2026 · Open, Classified
    Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
  • Z-2679-2026 · Jun 10, 2026 · Open, Classified
    Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
  • Z-2678-2026 · Jun 10, 2026 · Open, Classified
    Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
  • Z-1467-2021 · Feb 22, 2021 · Terminated
    AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and cathete

Other INTRODUCER, CATHETER devices

All INTRODUCER, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.