SafeSheath IIRecalls & reported problems across all models

We found 14 models of SafeSheath II by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2017 and Aug 25, 2026 — classified as 2 deaths, 15 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (104 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. 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

Most reported SafeSheath II problems

SafeSheath II models

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

• SafeSheath® II SS6

  INTRODUCER, CATHETER
  48 reports
• SafeSheath® II SS7

  INTRODUCER, CATHETER
  42 reports
• SafeSheath® II SS9

  INTRODUCER, CATHETER
  1 death21 reports
• SafeSheath® II 667460-300

  INTRODUCER, CATHETER
  10 reports
• SafeSheath® II SS8

  INTRODUCER, CATHETER
  5 reports
• SafeSheath® II 667462-300

  INTRODUCER, CATHETER
  4 reports
• SafeSheath® II SSCL9

  INTRODUCER, CATHETER
  3 reports
• SafeSheath® II SS95

  INTRODUCER, CATHETER
  3 reports
• SafeSheath® II SSL6

  INTRODUCER, CATHETER
  3 reports
• SafeSheath® II 667464-300

  INTRODUCER, CATHETER
  2 reports
• SafeSheath® II SSL9

  INTRODUCER, CATHETER
  1 death2 reports
• SafeSheath® II 667470-300

  INTRODUCER, CATHETER
  1 report
• SafeSheath® II SS11

  INTRODUCER, CATHETER
  1 report
• SafeSheath® II SSL11

  INTRODUCER, CATHETER
  1 report

Recent SafeSheath II adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN INADVERTENTLY PERFORATED THE LEAD THROUGH THE PATIENT'S HEART. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY AFTER THE PERFORATION. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND A HOSPITAL CODE BLUE' WAS INITIATED. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR STERNOTOMY IN ORDER TO CLOSE THE PERFORATION. THE LEAD WAS NOT IMPLANTED. PROCEDURE ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT NOT RETURNING. MEDTRONIC CUSTOMER REPORTED THERE IS NO COMPLAINT CONCERNING THE OSCOR PRODUCT ON THIS EVENT. NON-COMPLAINT JUSTIFICATION AND RATIONALE: THERE WAS NO ALLEGATION AGAINST THE OSCOR INTRODUCER. THE MDT REP STATED THAT THE RV LEAD HAD PERFORATED THE PATIENT'S HEART TISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NOT REPORTABLE; INFORMATION/ANALYSIS DOES NOT INDICATE A PRODUCT MALFUNCTION. THERE IS NO INDICATION OF A FAILURE OF THIS MARKETED DEVICE TO MEET CUSTOMER OR USER EXPECTATIONS FOR QUALITY OR TO MEET PERFORMANCE SPECIFICATIONS; THUS, THE ASSOCIATED LINE-ITEM TASKS WILL BE PROCESSED AS A NON-COMPLAINT. (B)(6). (B)(6).

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 23336413 ↗
• 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 19, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DEVICE DISCARDED. NO PHOTOS OR VIDEOS AVAILABLE. THERE WERE NO DELAYS. ONLY THE LEAD WENT INTO CATHETER. DURING SLITTING PROCESS THE DEFLECTION CABLES THAT ALLOW THE DEFLECT BECAME CAUGHT IN SLITTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289505 ↗
• 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 28, 2025Break; Break

  I WOULD LIKE TO BRING TO YOUR ATTENTION THAT ON (B)(6) 2025 DURING ONE OF OUR EP PROCEDURES, ONE OF YOUR 8 FRENCH SAFE SHEATH II PRODUCTS HAD FRACTURED AND BECAME SEPARATED AT THE WINGTIP HUB AND ITS SHEATH BODY DURING THE SPLITTING PROCESS. THIS FAILURE CAUSED THE SHEATH BODY TO BE LEFT INSIDE THE VESSEL OF THE PATIENT. FORTUNATELY, THE PHYSICIAN WAS ABLE TO EXTRACT THE REMAINING SHEATH FROM THE PATIENT. THIS IS MEANT FOR YOUR AWARENESS AND CURRENTLY REMAINS AN ISOLATED INCIDENT WITH THIS PRODUCT FROM THE LOT NUMBER WE HAVE. INFORMATION PROVIDED IS FROM THE IMPLANTING PHYSICIAN. NO PATIENT INFORMATION PROVIDED. THE PROCEDURE PERFORMED IS A DUAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE EVENT OCCURRED AT (B)(6) HOSPITAL. THERE WAS NO DELAY IN THE PROCEDURE AND NO MEDICAL OR SURGICAL INTERVENTION PROVIDED. THE PHYSICIAN USED PICKUPS TO PULL REMAINING SHEATH OUT OF PATIENT VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920767 ↗
• 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 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A POST OPERATIVE CHECK ON THE DAY OF IMPLANT THE PATIENT REPORTED FEELING SOME PAIN THEIR UPPER LEFT CHEST. A CHEST X-RAY WAS PERFORMED AND THE PHYSICIAN SUSPECTED THAT THE DISTAL END OF THE EXTRAVASCULAR (EV) LEAD MAY HAVE ENTERED THE LEFT PLEURA. FIVE DAYS LATER SOME DEVICE SITE PAIN WAS STILL PRESENT, BUT THE "LUNG PAIN" HAD EASED. THE PATIENT WILL CONTINUE TO BE MONITORED, AND THE EV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 27/MAR/2025 THERE WAS NO DEVICE PERFORMANCE FAILURE REPORTED BY THE USER, FOR THE SSCL9. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. SUBMISSION FOR ADMINISTRATIVE PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709944 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING IMPLANT, THE LUER HUB WAS DETACHED FROM THE INTRODUCER SHEATH AND THE VALVE END REMAINED AFTER PEELING AWAY. THE INTRODUCER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. CUSTOMER DISCARDED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643898 ↗
• 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 ↗
• 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 ↗

Other Oscor Inc. products

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• 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