SafeSheath® II SS7Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 30891492002228), received between Apr 29, 2019 and Jun 19, 2025 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (35 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 42 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 21, 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. DEVICE WILL BE RETURNED FOR EVALUATION. (B)(6) 2024 NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DP21164 IS THE REPORTED LOT NUMBER. THE ISSUE WAS DISCOVERED DURING THE IMPLANT PROCEDURE. REQUESTED FROM SALES REPRESENTATIVE, ALL ADDITIONAL ANSWERS. (B)(6) 2024 THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING MOSQUITO SCISSORS TO HELP SEPARATE THE SHEATH. THERE WAS A MINIMAL PROCEDURE DELAY OF NO MORE THAN 2-MINUTES; NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. AN IMAGE WAS PROVIDED BY THE CUSTOMER PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750499 ↗
• MalfunctionNov 21, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  HEMOSTATIC VALVE DID NOT BREAK APART AS INTENDED. ON (B)(6) 2024 IT WAS REPORTED THAT DURING THE PACEMAKER IMPLANT PROCEDURE THE INTRODUCER SHEATH RUBBER VALVE WAS NOT SPLITTING PROPERLY AND GETTING STUCK TO THE LEAD. MULTIPLE SHEATHS WERE ATTEMPTED TO BE USED, HOWEVER REGARDLESS OF SIZE, THE SAME ISSUE OCCURRED. THE SHEATHS WERE ATTEMPTED TO BE USED, HOWEVER, THEY WERE REMOVED AND NOT REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MOSQUITO SCISSORS TO PULL RUBBER VALVE APART. THERE WAS A MINUTE OR SO DELAY, BUT NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO PATIENT INFORMATION PROVIDED AS NO REP PRESENT AS TIME OF OCCURRENCE. IT WAS REPORTED AS A SAFE SHEATH II 7F, THE LOT NUMBER IS UNKNOWN, NO INFORMATION GIVEN BY HEALTH CARE PROFESSIONAL AND NO REPRESENTATIVE WAS PRESENT AT TIME OF OCCURRENCE. THERE ARE NO PICTURES, IMAGES, OR VIDEOS AVAILABLE. ASKED FOR THE LOCATION OF THE DEVICE AND IT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746602 ↗
• 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 20695359 ↗
• MalfunctionNov 14, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  (B)(6) 2024: PRODUCT IS NOT RETURNING. THE SALES REP HAS REQUESTED THIS INFORMATION FROM THE FACILITY AND FACILITY HAS REFUSED TO PROVIDE A RESPONSE; HENCE IT IS ASKED AND UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689183 ↗
• MalfunctionOct 28, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  10/29/2024: THE CUSTOMER REPORTED THAT POSSIBLY 7 PATIENTS INVOLVED IN 7 DIFFERENT PROCEDURES. TYPE OF PROCEDURE STATED AS IMPLANT OF IMPLANTABLE PULSE GENERATOR (IPG). NO PROCEDURE DELAY AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. MOSQUITO SCISSORS USED TO PULL RUBBER VALVE APART, PROCEDURE COMPLETED SUCCESSFULLY. CUSTOMER STATED VIDEO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547079 ↗
• MalfunctionOct 21, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ON (B)(6) 2024, THE SAFESHEATH WAS UTILIZED BY THE CUSTOMER WHO COMPLAINED THAT THE HUB OF THE SAFESHEATH DID NOT TEAR APPROPRIATELY WHEN BEING REMOVED ONCE THE LEAD WAS IN POSITION. THERE WERE NO ADVERSE OUTCOMES FOR THIS EVENT. THE HUB WAS EVENTUALLY ABLE TO BE SPLIT AND TORN, AND THE LEAD STAYED IN POSITION DURING SAFESHEATH REMOVAL. NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION; SAFESHEATH DID NOT TEAR APPROPRIATELY WHEN BEING REMOVED ONCE THE LEADS WERE IN POSITION. THERE WERE NO ADVERSE OUTCOMES FOR THIS EVENT. THE HUB WAS EVENTUALLY ABLE TO BE SPLIT AND TORN, AND THE LEAD STAYED IN POSITION DURING SAFESHEATH REMOVAL. PROCEDURE WAS COMPLETED SUCCESSFULLY. REQUEST SENT TO SALES REPRESENTATIVE TO CONFIRM IF THERE WAS A DELAY IN THE PROCEDURE, IF YES, HOW LONG; ADDITIONALLY, ARE PICTURES, IMAGES, OR VIDEOS AVAILABLE. DEVICE IS AVAILABLE FOR INVESTIGATION. ON (B)(6) 2024, THERE WAS NO DELAY IN THE PROCEDURE AND NO IMAGES ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495939 ↗
• MalfunctionOct 7, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE HUBS OF THE SAFESHEATHS DID NOT TEAR APPROPRIATELY WHEN THEY WERE BEING REMOVED ONCE THE LEADS WERE IN POSITION. THERE WERE NO ADVERSE OUTCOMES FOR THIS EVENT. THE HUBS WERE EVENTUALLY ABLE TO BE SPLIT AND TORN, AND THE LEADS STAYED IN POSITION DURING SAFESHEATH REMOVAL.NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384433 ↗
• MalfunctionOct 4, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED FROM NEW ZEALAND THAT DURING THE LEAD IMPLANT PROCEDURE, WHEN THE INTRODUCER SHEATH WAS SPLIT, THE HEMOSTATIC VALVE STAYED ATTACHED TO THE IMPLANTED LEAD AND THE OPERATOR HAD TO CUT OFF WITH SCISSORS AND SCALPEL. THE INTRODUCER SHEATH WAS CONTAMINATED WITH BLOOD DURING THE PROCEDURE AND THE PROCEDURE TIME WAS PROLONGED. THE INTRODUCER WAS ATTEMPTED, NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369771 ↗
• MalfunctionOct 3, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE HUBS OF THE INTRODUCER CATHETERS DID NOT TEAR APPROPRIATELY WHEN THEY WERE BEING REMOVED. THE HUBS WERE EVENTUALLY ABLE TO BE SPLIT AND TORN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT RETURNING. THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS ISSUE. THE SAFESHEATH WAS UTILIZED BY THE CUSTOMER WHO COMPLAINED THAT THE HUB OF THE SAFESHEATH DID NOT TEAR APPROPRIATELY WHEN BEING REMOVED ONCE THE LEAD WAS IN POSITION. THERE WERE NO ADVERSE OUTCOMES FOR THIS EVENT. THE HUB WAS EVENTUALLY ABLE TO BE SPLIT AND TORN, AND THE LEAD STAYED IN POSITION DURING SAFESHEATH REMOVAL. PROCEDURE WAS COMPLETED SUCCESSFULLY. NORMAL ANATOMY- SUBCLAVIAN PUNCTURE USED, THERE WAS NO ISSUE PLACING THE SAFESHEATHS OVER THE WIRE. IT WAS A HUB ISSUE, THE HUBS BROKE (WINGS CAME OFF) WHEN THE DOCTOR ATTEMPTED TO SPLIT THE HUB BEFORE THEN PULLING BACK AND TEARING THE REST OF THE SHEATH - SO ANATOMY WOULDN'T HAVE ANY INFLUENCE ON THE HUB WINGS BREAKING. ONE 5076 LEAD WAS INSERTED INTO EACH SAFESHEATH ONCE THE INTRODUCER WIRE WAS REMOVED (SELDINGER TECHNIQUE USED). PHYSICIAN MANAGED TO SPLIT THE BROKEN HUBS AND REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362120 ↗
• MalfunctionSep 30, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE INTRODUCER SHEATH WAS HARD TO TEAR WITH HAND. FORCE WAS USED TO TRY TO TEAR, HOWEVER IT WOULD NOT TEAR. THE PHYSICIAN USED A SCISSOR TO CUT THE INTRODUCER SHEATH TO AVOID RISK TO SLASH LEAD INSULATOR. THE SHEATH WAS SUCCESSFULLY CUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO PROCEDURE DELAY REPORTED, AND NO INTERVENTION REPORTED. FACILITY REFUSED TO RETURN DEVICE. PATIENT IS A 45-YEAR-OLD, FEMALE. THE PROCEDURE WAS A DUAL CHAMBER PACEMAKER IMPLANTATION. THE PROCEDURE HAS BEEN COMPLETED WITHOUT ANY COMPLICATIONS. NO OTHER DEVICES WERE PUT IN THIS SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334855 ↗
• MalfunctionAug 28, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  EVENT TOOK PLACE DURING IMPLANT OF PACEMAKER W3DR01 WITH 4076 AND 3830 LEADS. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN PEELING AWAY THE INTRODUCER IT WAS STICKING TOGETHER AND WOULD NOT PEEL AWAY EASILY. THE INTRODUCER WAS ATTEMPTED NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.THERE WAS A DELAY OF LESS THAN 30 MINUTES. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085822 ↗
• MalfunctionJul 10, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER REPORTED A PROBLEM WITH SAFESHEATH. THIS HAS HAPPENED A FEW TIMES. PART OF THE WHITE PART BREAKS OFF SEPARATELY FROM REST OF THE SHEATH AND IF DOCTOR WAS NOT OBSERVANT, IT MIGHT WIND UP IN THE POCKET. PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714114 ↗
• MalfunctionMay 1, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  CUSTOMER STATED ISSUE UNLIKELY CAUSED BY PHYSICIAN AS SAME PHYSICIAN HAS DONE MANY IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221583 ↗
• MalfunctionApr 15, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT INTRA-OPERATIVE THE INTRODUCER SHEATH EXHIBITED A SEVERE PEELING ISSUE, WHICH TOOK A LOT OF EFFORT, CAUSED THE PACING LEAD POSITION TO DESTABILIZE, AND LED TO LEAD REPOSITIONING AND A DELAY IN THE PROCEDURE, AND LONGER TIME EXPOSURE OF THE POCKET. THE INTRODUCER SHEATH WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107492 ↗
• MalfunctionMar 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ADDITIONAL INFORMATION, "OUR SYSTEM SHOWS THAT EVENT (B)(6) HAS ALL THREE ITEMS RETURNED (3X SHEATHS DP19201) (B)(6) AND (B)(6) ARE COMPLAINTS BUT THERE IS NO COMPLAINT (NO ALLEGATION) AGAINST (B)(6) ." THERE WERE NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966301 ↗
• MalfunctionMar 1, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER REPORTED THAT THE INNER VALVE DID NOT BREAK WHEN SHEATH WAS BEING SLIT, PHYSICIAN HAD TO CUT THE VALVE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816812 ↗
• MalfunctionFeb 10, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  NO EVENT DETAILS PROVIDING WHAT BROKE ON THE SHEATH OR WHAT THE PHYSICIAN HAD TO CUT ON THE SHEATH IN ORDER TO REMOVE THE SHEATH. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED. NO ADDITIONAL EVENT INFORMATION PROVIDED CONCERNING ANY DELAY IN THE PROCEDURE. NO ADDITIONAL EVENT INFORMATION PROVIDED CONCERNING A MEDICAL OR SURGICAL INTERVENTION. NO PICTURES OR VIDEO ARE AVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682725 ↗
• MalfunctionDec 19, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER REPORTED THAT DURING A PACEMAKER IMPLANTATION PROCEDURE PEEL AWAY SHEATH WASN'T WORKING PROPERLY. THE INNER PLASTIC PIECE UNDER THE FOAM IS NOT BREAK AWAY. THE STAFF ARE HAVING TO EITHER PULL HARD OR USE SCISSORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359915 ↗
• MalfunctionDec 19, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AN INVENTORY REPRESENTATIVE FOR THE CATH LAB AT (B)(6) HOSPITAL IN NAPLES REPORTED THEY WERE HAVING MULTIPLE ISSUES WITH THE SS7 MODEL FOR SAFESHEATH II LOT #DP-20033. NO ADDITIONAL INFORMATION AVAILABLE, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357009 ↗
• MalfunctionDec 7, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER STATED THAT ONE HALF OF THE HUB SNAPPED OFF WHEN SPLITTING THE SHEATH. DR. USED FORCEPS TO COMPLETE THE SHEATH SPLIT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284302 ↗
• MalfunctionOct 24, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE DOCTOR HAD PLACED A DELIVERY SYSTEM THROUGH THE SHEATH FOLLOWED BY A HIS LEAD. ONCE THE LEAD WAS PLACED THE DELIVERY SYSTEM WAS CUT AWAY. AFTERWARDS THE DOCTOR ATTEMPTED TO PEEL AWAY THE SHEATH WHICH DID NOT SEPARATE CAUSING THE LEAD TO DISLOCATE. A NEW SHEATH WAS USED TO REPLACE THE LEAD. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998587 ↗
• 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: 1035166-2023-00101 - (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871203 ↗
• MalfunctionSep 21, 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 THE SAFESHEATH SS7 INTRODUCER SYSTEM, AS SPLITTING WAS NOT COMPLETE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PATIENT HAS A MEDICAL HISTORY OF CARDIOMYOPATHY. THE ICD IMPLANT WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788029 ↗
• MalfunctionAug 3, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED INTRA OPERATIVELY THAT THE VALVE PART OF THE INTRODUCER WAS NOT CRACKING AWAY CLEANLY AND WAS BREAKING OFF FROM THE PEEL AWAY INTRODUCER, IT WAS NOTED THAT THIS HAPPENED WITH SEVERAL PRODUCTS IN THE LOT. THE INTRODUCER WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449953 ↗

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