SafeSheath® II SS6Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 30891492002211), received between Oct 10, 2018 and Jul 23, 2025 — classified as 1 injury, 47 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (42 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. 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PEEL AWAY SHEATHS DID NOT PEEL. A SCISSORS WAS NEEDED TO CUT THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576390 ↗
• MalfunctionJul 23, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  PATIENT IN EP LAB FOR PACEMAKER REPLACEMENT. 6F SAFESHEATH USED FOR LEAD INSERTION. WHEN MD SPLIT SAFESHEATH, THE INNER RING OF THE SHEATH DID NOT SPLIT IN HALF AND REMAINED INTACT. MD ABLE TO MANUALLY SPLIT RING AND REMOVE. THIS HAS HAPPENED IN THE LAB IN THE PAST WITH THE SAME SIZE SHEATH. LOT# DP20264. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575174 ↗
• MalfunctionJun 6, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER REPORTED THAT AN INCIDENT HAS OCCURRED WITH THE FOLLOWING MEDICAL DEVICE: 6F VALVE INTRODUCER WITH MODEL NUMBER 7460, (LOT NUMBER S9184150). THIS INCIDENT WAS REPORTED ON (B)(6) 2024 BY THE CARDIOLOGY OUTPATIENT CLINIC OF (B)(6) HOSPITAL CENTER (B)(6). INDEED, DURING THE INSERTION OF AN IMPLANTABLE ECG MONITOR, THE INTRODUCER DID NOT PEEL CLEANLY, AND A PASTE WAS FORMED, PREVENTING THE STIMULATION LEAD FROM BEING INSERTED. THE DEVICE WAS NOT USED - ATTEMPTED. THE CUSTOMER STATED PROLONGED SURGERY. THE DEFECTIVE DEVICE HAS BEEN DISPOSED, AND IT IS NOT AVAILABLE. 04/JUN/2025 CUSTOMER PROVIDED ADD'L INFO FROM GFE 1: NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO PATIENT INFORMATION WAS PROVIDED. NO SPECIFIC TIME FOR DELAY WAS NOTED, HOWEVER IT DID NOT APPEAR TO BE SIGNIFICANT OUTSIDE OF REPEATING THE PROCEDURE WITH ANOTHER INTRODUCER. IT APPEARS A SECOND INTRODUCER MAY HAVE BEEN USED TO IMPLANT THE STIMULATION LEAD. NO ADDITIONAL INTERVENTION REPORTED OUTSIDE OF CURRENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157837 ↗
• MalfunctionMay 19, 2025Defective Device; Activation Failure

  MEDICAL DOCTOR (MD) WENT TO CRACK THE WINGS OF THE PEEL-AWAY SAFESHEATH, THE RUBBER GROMMET ON THE INSIDE OF THE SHEATH DID NOT SPLIT AS DESIGNED. THE RUBBER GROMMET THEN STAYED ON THE LEAD AND MD HAD TO PULL IT APART. THIS THEN LEAVES A CHANCE OF PARTICLES FALLING IN THE POCKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043672 ↗
• MalfunctionApr 2, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  PHYSICIAN WAS PERFORMING AN IMPLANT, AND HE NOTED THE DILATOR WAS DIFFICULT TO PASS THROUGH THE 6F SAFESHEATH BUT MANAGED WITH A LITTLE MORE FORCE THAN USUALLY REQUIRED. WHEN BREAKING AT THE HUB, HE NOTED IT TOOK A LITTLE MORE EFFORT THAN USED TO. THE INTRODUCER WAS REMOVED AND A NEW SAFESHEATH FROM A DIFFERENT LOT WAS USED INSTEAD. AFTER THE PROCEDURE THE PHYSICIAN CRACKED THE HUB OF THE DISCARDED SHEATH OUT OF INTEREST AND NOTED IT WAS DIFFICULT TO SPLIT. IT APPEARS THE ISSUE WAS WITH PEELING THE INTRODUCER. NO ADDITIONAL PROCEDURE DETAILS WERE PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT THAT THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. NO PICTURES OR VIDEOS RELATED TO THE MALFUNCTIONED DEVICE ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751687 ↗
• MalfunctionApr 1, 2025Material 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. 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. CUSTOMER WOULD LIKE ONE MORE LOT ADDED DOR14006. UNOPENED PACKET OF 5 SHEATHS BUT CUSTOMER SUSPECTS WILL HAVE SAME VALVE ISSUE. PRODUCT EXPECTED TO RETURN. 14/MAR/2025 ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER REPORTED THERE WAS ONLY A MINUTE OR SO DELAY IN THE PROCEDURE. MOSQUITO SCISSORS USED TO PULL RUBBER VALVE APART TO RESOLVE THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744720 ↗
• MalfunctionApr 1, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PHYSICIAN STATED THE DILATOR WAS DIFFICULT TO PASS THROUGH THE 6F SAFESHEATH BUT MANAGED WITH A LITTLE MORE FORCE THAN USUALLY REQUIRED. WHEN BREAKING AT THE HUB HE NOTED IT TOOK A LITTLE MORE EFFORT THAN IT USED TO. AFTER THE PROCEDURE THE PHYSICIAN CRACKED THE HUB OF THE DISCARDED SHEATH OUT OF INTEREST AND NOTED IT WAS DIFFICULT TO SPLIT. NO HARM TO PATIENT. THE TYPE OF PROCEDURE WAS AN IMPLANT OF PULSE GENERATOR AND LEADS. IT APPEARS THERE WAS A DELAY IN THE PROCEDURE IN ORDER TO USE ADDITIONAL PRODUCTS, HOWEVER IT IS UNKNOWN IF THIS WAS GREATER THAN 30 MINUTES. REPLACEMENT SAFESHEATH LOT WAS FROM THE SAME LOT AS REPORTED DEFECTIVE. PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741711 ↗
• MalfunctionMar 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DURING THE IMPLANT OF A CARDIAC RHYTHM MAINTENANCE DUAL CHAMBER PACEMAKER SYSTEM (PACEMAKER WITH TWO LEADS), THE PHYSICIAN WAS ATTEMPTING TO PEEL AWAY SHEATH AFTER PLACING THE RV (RIGHT VENTRICLE) LEAD. WHEN BREAKING SHEATH TO PEEL AWAY FROM THE PACEMAKER LEAD, THE SHEATH VALVE SEPARATED FROM SHEATH AND DID NOT SPLIT. HAD TO TAKE SCISSORS TO CUT THROUGH VALVE TO COMPLETE THE IMPLANT PROCEDURE. THERE WAS A SHORT PROCEDURE DELAY (1-2 MINUTES), AND MEDICAL/SURGICAL INTERVENTION AS PHYSICIAN USED SMALL SURGICAL SCISSORS TO CUT THE VALVE WHEN IT SEPARATED FROM HUB AND DID NOT TEAR. THE IMPLANT OF CARDIAC RHYTHM MAINTENANCE DUAL CHAMBER PACEMAKER SYSTEM (PACEMAKER WITH TWO LEADS) WAS SUCCESSFULLY COMPLETED. NO HARM TO PATIENT. STRICT POLICY AGAINST THE USE OF PHONES/CAMERAS IN OPERATING ROOM. NO PHOTOS/VIDEOS ALLOWED. PER REP, THE PRODUCT WAS DISCARDED BY THE FACILITY. PATIENT INFORMATION WAS PROVIDED. PRODUCT SAFESHEATH II SS6 HAS MODEL NUMBER 398339 AND BATCH NUMBER / SERIAL NUMBER (B)(6). (B)(4) IS THE DISTRIBUTOR WE BUY THEM FROM. MANUFACTURER IS OSCOR NOW OWNED BY INTEGER (SO, "OSCOR" IS THE BRAND IF I AM UNDERSTANDING THE QUESTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551841 ↗
• MalfunctionJan 10, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, WHEN THE SHEATH WAS SPLIT, THE HEMOSTATIC VALVE WAS LEFT ATTACHED TO THE LEAD WHEN IT SHOULD ALSO HAVE SPLIT. THE VALVE HAD TO BE CUT OFF WITH A SCALPEL OR SCISSORS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124418 ↗
• MalfunctionDec 9, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ADDITIONAL INFORMATION RECEIVED 04/DEC/2024: AS PER THE EVENT DESCRIPTION, MULTIPLE SHEATHS WERE ATTEMPTED DURING THE PROCEDURE, SO PLEASE TELL US HOW MANY WERE USED. ONE, WAS ATTEMPTED BUT NOT SUCCESSFUL, THEN A NEW ONE WHICH WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879205 ↗
• MalfunctionDec 9, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  SAFE SHEATH DID NOT SPLIT PROPERLY. DOCTOR WAS UNHAPPY BECAUSE THIS HAS HAPPENED MULTIPLE TIMES - SHE HAD TO VERY SLOWLY AND CAREFULLY RETRIEVE IT FROM THE PATIENT'S SUBCLAVIAN VEIN WITHOUT DISLODGING HER LEAD. NOTED THIS SAFE SHEATH HAS THE SAME LOT NUMBER AS ONE THAT DID NOT SPLIT PROPERLY 2 MONTHS PRIOR. DEVICE RETAINED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878853 ↗
• MalfunctionDec 9, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  06/JAN/2025 PER CUSTOMER, IT APPEARS THAT THESE 2 WERE MIXED UP. PLEASE PROCEED WITH ANALYZING THIS PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878331 ↗
• MalfunctionNov 21, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  SAFE SHEATH DID NOT SPLIT PROPERLY. DOCTOR WAS VERY UNHAPPY - SHE HAD TO VERY SLOWLY AND CAREFULLY RETRIEVE IT FROM THE PATIENT'S SUBCLAVIAN VEIN WITHOUT DISLODGING HER LEAD. THE EVENT OCCURRED INTRAOPERATIVELY. NO PATIENT HARM. THE PROCEDURE WAS SUCCESSFUL (PRODUCT REMAINS IMPLANTED/PROCEDURE COMPLETED). NO ADVERSE EVENT REPORTED. PRODUCT AVAILABLE FOR RETURN. 14/NOV/2024 WE RECEIVED THE INFORMATION FROM THE CUSTOMER THAT FOR THE SENT COMPLAINT (B)(4) - THERE WAS A TYPO ON THE COMPLAINT FORM AND DP20524 IS THE CORRECT LOT NUMBER. ON (B)(6) 2024 DURING THIS PROCEDURE A SINGLE SOLIA S LEAD WAS INSERTED IN THE SHEATH. THE DELAY WOULD HAVE BEEN LESS THAN 5-MINUTES, BUT THE OPERATOR EXPRESSED FRUSTRATION AND DISMAY, COMPLAINING THAT THERE MUST BE A FAULT WITH THE SHEATHS BECAUSE THEY WEREN'T SPLITTING PROPERLY, AND IT HAD HAPPENED MULTIPLE TIMES PREVIOUSLY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO PICTURES OF VIDEOS TAKEN SINCE DEVICE IS AVAILABLE FOR EVALUATION. SUMMARY: THE EVENT OCCURRED INTRAOPERATIVELY. DURING THE PROCEDURE A SINGLE SOLIA S LEAD WAS INSERTED IN THE SHEATH, SAFESHEATH DID NOT SPLIT PROPERLY. DOCTOR WAS VERY UNHAPPY - SHE HAD TO VERY SLOWLY AND CAREFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750085 ↗
• MalfunctionNov 15, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695527 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694793 ↗
• MalfunctionNov 14, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ADDITIONAL INFORMATION RECEIVED ON 11/08/2024: THE SHEATHS WERE ATTEMPTED, REMOVED NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PROCEDURE DELAY OF NO MORE THAN 2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689437 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546000 ↗
• MalfunctionOct 14, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, WHEN THE SHEATH WAS SPLIT, THE HEMOSTATIC VALVE WAS LEFT ATTACHED TO THE LEAD WHEN IT SHOULD HAVE SPLIT. THE VALVE HAD TO BE CUT OFF WITH A SCALPEL OR SCISSORS. THE DEVICE WILL NOT BE RETURNED, HOSPITAL HAS DEVICE AND REFUSED TO RETURN. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION, HOWEVER, THERE WAS A PROCEDURE DELAY OF LESS THAN 30 MINUTES. THE ISSUE WAS RESOLVED, THE DOCTOR HAD TO CUT OFF THE VALVE MANUALLY BUT IT DOES IMPOSE A RISK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT; NO PATIENT INFORMATION IS AVAILABLE, THIS IS CONSIDERED CONFIDENTIAL. CUSTOMER WAS ABLE TO PROVIDE THE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439957 ↗
• MalfunctionAug 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING PACEMAKER AV INSERTION PROCEDURE THE HEMOSTATIC VALVE WAS NOT SPLITTING APART. VALVE WAS CUT WITH SCISSORS AND PROCEDURE WAS CONTINUED. THERE WAS 2 MIN DELAY REPORTED. DEVICE WAS DISCARDED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046858 ↗
• MalfunctionAug 22, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DURING A DUAL PACEMAKER GENERATOR CHANGE, NEW RV LEAD PROCEDURE ANOTHER EP PHYSICIAN PEELED AWAY SAFE SHEATH II FROM THE LEAD, AND THE DISC DID NOT SPLIT IN HALF. THE PHYSICIAN USED SCISSORS TO CUT THE DISC, AND THE SAFE SHEATH AND DISC WERE REMOVED. NO HARM NO INJURY TO PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. THE STAFF REMOVED ALL PRODUCT WITH THE SAME LOT NUMBER FROM THE AREA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT THIS TIME, WE DO NOT HAVE EITHER DEVICE. IT WAS REMOVED FROM MY OFFICE AND WAS POSSIBLY DISCARDED. THERE ARE NO PICTURE OR VIDEOS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040558 ↗
• MalfunctionAug 6, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  WE HAVE BEEN HAVING SOME ISSUES WITH THE VALVES ON THE SAFE SHEATHS. WHEN PEELED THE VALVE DOESN'T SPLIT AND NEEDS TO BE CUT. PRODUCT WAS NOT KEPT BY FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923593 ↗
• MalfunctionAug 6, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  (B)(6) 2024 - DURING A DUAL PACEMAKER/ GENERATOR CHANGE / NEW RV LEAD PROCEDURE ANOTHER EP PHYSICIAN PEELED AWAY SAFE SHEATH II FROM THE LEAD, AND THE DISC DID NOT SPLIT IN HALF. THE PHYSICIAN USED SCISSORS TO CUT THE DISC, AND THE SAFE SHEATH AND DISC WERE REMOVED. NO HARM NO INJURY TO PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. THE STAFF REMOVED ALL PRODUCT WITH THE SAME LOT NUMBER FROM THE AREA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT THIS TIME, WE DO NOT HAVE EITHER DEVICE. IT WAS REMOVED FROM MY OFFICE AND WAS POSSIBLY DISCARDED. THERE ARE NO PICTURE OR VIDEOS AVAILABLE. COMPLAINT SENT TO FDA BY PHYSICIAN. ADDITIONAL COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920365 ↗
• InjuryJul 12, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  CUSTOMER HAS COMPLAINED ABOUT THE PRESSURE PRODUCT SAFE SHEATH II. PRODUCT IS THE 7460 6F SAFE SHEATH. REF: 667460-001. LOT: DP20955. MANUFACTURING DATE: 10-JAN-2024. EXPIRY: 01-JAN-2029. IT WAS REPORTED THAT DURING A PACEMAKER IMPLANT PROCEDURE, THE VALVE OF THIS SAFE SHEATH WAS OBSERVED TO BE DIFFICULT TO SPLIT AND RESULTED IN PLASTIC DEBRIS COMING FREE FROM THE SHEATH AND FALLING INTO THE DEVICE POCKET. ADDITIONAL INTERVENTION WAS PERFORMED, AND THE POCKET WAS EXCAVATED. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE. THE SHEATH WAS DISPOSED OF AT THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PATIENT DETAILS UNKNOWN DUE TO EEA REGS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, FULLY RECOVERED. IT APPEARS DELAY DID OCCUR AS ADDITIONAL INTERVENTION WAS REQUIRED, KNOWN IF THIS WAS ABOVE OR BELOW 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 19729218 ↗
• MalfunctionJul 11, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  HEMOSTATIC TEAR-AWAY INTRODUCER SYSTEM WITH INFUSION SIDE PORT. THE ITEM IS USED TO IMPLANT PACEMAKER LEADS. ONCE THE LEADS ARE IN POSITION THE SHEATH IS SPLIT OPEN AND REMOVED. IT HAS BEEN OBSERVED ON SEVERAL OCCASIONS THAT WHEN THE SHEATH IS SPLIT, DEBRIS IS LOST AND HAS BEEN FALLING INTO THE PACEMAKER POCKET. THE HEMOSTATIC VALVE SHOULD SPLIT CLEANLY. THE ISSUE APPEARS TO ONLY BE AFFECTING 6F SHEATHS. EVENT OCCURRED WITH FOUR (4) PATIENTS. ITEMS TOOK OUT OF CIRCULATION. SOURCING REPLACEMENT ON-GOING. PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721670 ↗
• MalfunctionJul 11, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  HEMOSTATIC TEAR-AWAY INTRODUCER SYSTEM WITH INFUSION SIDE PORT. THE ITEM IS USED TO IMPLANT PACEMAKER LEADS. ONCE THE LEADS ARE IN POSITION THE SHEATH IS SPLIT OPEN AND REMOVED. IT HAS BEEN OBSERVED ON SEVERAL OCCASIONS THAT WHEN THE SHEATH IS SPLIT, DEBRIS IS LOST AND HAS BEEN FALLING INTO THE PACEMAKER POCKET. THE HEMOSTATIC VALVE SHOULD SPLIT CLEANLY. THE ISSUE APPEARS TO ONLY BE AFFECTING 6F SHEATHS. EVENT OCCURRED WITH FOUR (4) PATIENTS. ITEMS TOOK OUT OF CIRCULATION. SOURCING REPLACEMENT ON-GOING. PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721375 ↗

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 catheter