SafeSheath® II 667460-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20802526532447), received between Aug 17, 2017 and Aug 28, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT SHEATH THAT DID NOT BREAK WHEN THE PHYSICIAN SPLIT THE SHEATH. THE VALVE IS DESIGNED TO BREAK WHEN THE SHEATH IS SPLIT DURING LEAD IMPLANTATION. CASE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EVENT OR SURGICAL DELAY REPORTED. DOCTOR REMOVED THE VALVE, IT WAS PRE-SLIT AS EXPECTED AND IT SEPARATED IT WITH HIS FINGERS. DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086035 ↗
• MalfunctionMar 20, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DURING A DUAL CHAMBER PACEMAKER IMPLANT THE PHYSICIAN ATTEMPTED TO SPLIT SHEATH, AND PULL TABS TORE OFF BEFORE SHEATH SPLIT. HAPPENED WITH BOTH SHEATHS, PHYSICIAN COMMENTED THAT THIS HAS BEEN AN ONGOING ISSUE FOR ABOUT A MONTH. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943557 ↗
• MalfunctionAug 28, 2023Material Integrity Problem; Material Integrity Problem

  WHEN USING THE INTRODUCER, THE HUB FAILED TO CRACK AND SPLIT AWAY FROM THE LEAD IN ONE SINGLE ACTION. THIS RESULTED IN THE IMPLANTER HAVING TO USE SCISSORS TO SPLIT THE REMAINDER OF THE HUB AND THE INTRODUCER FROM OFF THE LEAD. THERE WAS NO ADVERSE PATIENT SIDE EFFECTS REPORTED, AND THE TWO LEADS AND PULSE GENERATOR WERE IMPLANTED WITHOUT ANY INCIDENT. THERE WAS NO PROCEDURE DELAY, NO PHOTOS ARE AVAILABLE, AND THE OUTER PACKAGING WAS NOT DAMAGED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE INTRODUCER WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630746 ↗
• MalfunctionSep 3, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT SUCCESSFUL IMPLANT PROCEDURE OF BOTH DEVICE AND LEADS. DURING IMPLANT PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTY PEELING THE SHEATH. THE ENTER PART OF THE VALVE DID NOT SPLIT. THE GUMMY PART AND A SMALL WHITE PLASTIC ROUND PART DID NOT SPLIT AND STAYED ON THE LEAD DURING PEELING AWAY. THE PHYSICIAN WAS ABLE TO CUT AWAY THE PARTS THAT STAYED AROUND THE LEAD WITHOUT ANY ISSUE. REFERENCES OF BOTH 6F SHEATHS ARE DP08787 AND DP09240. LOT NUMBER DP08787 WILL BE ADDRESSED UNDER MDR 1035166-2021-00093.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422634 ↗
• MalfunctionSep 3, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT SUCCESSFUL IMPLANT PROCEDURE OF BOTH DEVICE AND LEADS. DURING IMPLANT PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTY PEELING THE SHEATH. THE ENTER PART OF THE VALVE DID NOT SPLIT. THE GUMMY PART AND A SMALL WHITE PLASTIC ROUND PART DID NOT SPLIT AND STAYED ON THE LEAD DURING PEELING AWAY. THE PHYSICIAN WAS ABLE TO CUT AWAY THE PARTS THAT STAYED AROUND THE LEAD WITHOUT ANY ISSUE. REFERENCES OF BOTH 6F SHEATHS ARE DP08787 AND DP09240. LOT NUMBER DP09240 WILL BE ADDRESSED UNDER MDR 1035166-2021-00094.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422518 ↗
• MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE THE SCRUB TECH WAS PREPARING THE DEVICE FOR THE PHYSICIAN, THE CAP CAME OFF FROM THE DILATOR. THE DEVICE WASN'T USED AS IT WAS DISCARDED. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930368 ↗
• MalfunctionMar 30, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED THE USE OF SEVERAL SAFESHEATH II UNITS - EACH ONE THAT HE USED DID NOT 'BREAKAWAY'. HE HAD TO USE SOMETHING ELSE TO CUT IT. USED 2 DIFFERENT LOTS OF 7460 DP12235 & DP12274. THE PHYSICIAN ALSO HAD A 3RD ONE - COULDN'T FIND THE PACKAGING - WAS ALREADY IN THE TRASH AND CASE WAS FOR A COMPETITOR'S DEVICE. REFERENCE 1035166-2021-00031 FOR DP-12235. REFERENCE 1035166-2021-00033 FOR UNKNOWN LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588791 ↗
• MalfunctionMar 30, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED THE USE OF SEVERAL SAFESHEATH II UNITS - EACH ONE THAT HE USED DID NOT 'BREAKAWAY'. HE HAD TO USE SOMETHING ELSE TO CUT IT. USED 2 DIFFERENT LOTS OF 7460 DP12235 & DP12274. THE PHYSICIAN ALSO HAD A 3RD ONE - COULDN'T FIND THE PACKAGING - WAS ALREADY IN THE TRASH AND CASE WAS FOR A COMPETITOR'S DEVICE. REFERENCE 1035166-2021-00032 FOR DP-12274. REFERENCE 1035166-2021-00033 FOR UNKNOWN LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588546 ↗
• InjuryNov 20, 2019Leak/Splash; Manufacturing, Packaging or Shipping Problem; Leak/Splash; Manufacturing, Packaging or Shipping Problem

  ON (B)(6) 2019 CUSTOMER REPORTED THIS EVENT WITHOUT ANY EVENT DESCRIPTION. CUSTOMER REPORTED LOT NUMBER ONLY ON (B)(6) 2019 CUSTOMER REPORTED "SHEATH HAD FAULTY VALVE. THERE WAS NO IMPACT TO THE PATIENT, THE PATIENT IS STABLE. THE DEVICE WAS REPLACED WITH THE SAME PRODUCT. THE ISSUE WAS DETECTED DURING THE IMPLANT PROCEDURE, PRIOR TO POCKET CLOSURE. ADDITIONAL DEVICES USED ARE 7740/1007251 (RV LEAD) AND 7740/1007280 (RA LEAD). PRODUCT IS AVAILABLE FOR RETURN." ON (B)(6) 2019 CUSTOMER REPORTED " THE VALVE IS PART OF THE INTRODUCER SHEATH 7460-667460300 THAT WAS UTILIZED TO GAIN ACCESS FOR LEAD PLACEMENT. WHEN DILATOR WAS REMOVED FROM SHEATH AIR ENTERED THE SHEATH AND WENT TO THE PULMONARY ARTERY. INTRODUCER SHEATH WAS INSERTED IN LEFT SUBCLAVIAN. PROCEDURE COMPLETED IN STANDARD FASHION WITH NO OTHER ISSUES OUTSIDE OF THE AIR EMBOLUS." NO OTHER INFORMATION IS AVAILABLE AND NO OTHER ADVERSE EVENT REPORTED.

  Patient problems: Embolism; No Consequences Or Impact To Patient

  MAUDE report 9347721 ↗
• MalfunctionAug 17, 2017Difficult to Remove; Torn Material; Material Disintegration; Difficult to Remove; Torn Material

  THE CUSTOMER REPORTED 6F SAFESHEATH INTRODUCERS USED FOR PACEMAKER IMPLANT - WHEN PEELING AWAY THE MATERIAL SEEMED TO "DISINTEGRATE" AND NOT PEEL AWAY CLEANLY. OPERATOR HAD TO REMOVE INTRODUCER PIECE BY PIECE USING FORCEPS. BOTH SHEATHS (ATRIAL AND VENTRICULAR LEADS) WERE THE SAME. REMOVED PORTION AND UNUSED, UNOPENED SHEATHS FROM SAME LOT NUMBER RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6800123 ↗

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-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-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-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