Adelante SafeSheath II AS07013B5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885672002258), received between Jan 5, 2017 and Aug 23, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE DAY OF IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD DISLODGED, PERFORATED THE RIGHT VENTRICULAR APEX AND A PNEUMOTHORAX OCCURRED. A THORACOTOMY WAS PERFORMED TO REPAIR THE PERFORATION. IT WAS REPORTED THAT PERFORATION OF THE PATIENT'S RIGHT VENTRICLE DUE TO THE RIGHT VENTRICULAR LEAD; NOT THE SAFESHEATH. AS PER ADDITIONAL INFORMATION PHYSICIAN DID NOT BLAME THE INTRODUCER FOR PNEUMOTHORAX. PER THE ADDITIONAL INFORMATION RECEIVED ON 2019-07-02: THE 1 SS7 SAFESHEATH WAS OPEN BUT NOT USED AS IT WOULDN'T FLUSH. IT'S HARD TO KNOW WHAT SHEATH WAS USED WITH THE PNEUMOTHORAX. PER THE ADDITIONAL INFORMATION RECEIVED ON 2019-08-06: IT IS UNKNOWN WHAT SHEATH WAS IN USE WHEN THE PNEUMOTHORAX OCCURRED AND IT WAS JUST CONJECTURE BY THE FIELD REP THAT THE NEEDLE OF THE INTRODUCER CAUSED THE PNEUMOTHORAX. IT WAS CONFIRMED THAT SS7 SAFESHEATH ATTEMPTED BUT IT WAS UNABLE TO BE USED AS IT COULD NOT BE FLUSHED. THE ISSUE WITH THE SS7 WAS RESOLVED BY REMOVING IT AND IT WAS DISCARDED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PATIENT OUTCOME IS ALIVE WITH NO INJURY. ADVERSE EVENT WAS NOT ATTRIBUTE

  Patient problems: Perforation; Pneumothorax

  MAUDE report 8928019 ↗
• InjuryJan 5, 2017Difficult to Advance; Difficult to Advance

  PATIENT MEDICAL HISTORY: CONGENITAL HEART DISEASE/CONGENITAL AV BLOCK. WERE THERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT? NO. CLINICAL ACTIONS FOR PATIENT: NOT SPECIFIED. IF APPLICABLE, PLEASE PROVIDE ADDITIONAL DETAILS ABOUT WHAT HAPPENED TO THE PATIENT RELEVANT TO THIS EVENT NOT SPECIFIED. PATIENT STATUS: ALIVE - NO INJURY. ASSOCIATED WITH PATIENT: YES. PRODUCT EVENT DETAILS OTHER: A SECOND INTRODUCER OF THE SAME LOT# WAS OPENED AND PREPARED IN SAME FASHION; GUIDEWIRE WAS SUCCESSFULLY PASSED VIA DILATOR. BELOW ARE THE DETAILS FOR PRODUCT - MODEL NO: SS7, SERIAL/LOT NO: DP04654, DESCRIPTION: PLI KIT SS7 SAFESHEATH II 7FR 13 CM. IMPLANTABLE: NO. REPLACED BY MDT PRODUCT: YES. PRODUCT EVENT DETAILS: EVENT DETAILS FOR PLI KIT SS7 SAFESHEATH II 7FR 13 CM MODEL NUMBER: SS7 SERIAL OR LOT NUMBER: DP04654. SELECT ALL THAT APPLY: OTHER PRODUCT ISSUE. PLEASE SPECIFY: INCLUDED J-TIPPED GUIDEWIRE WOULD NOT ADVANCE PAST/THROUGH OPEN LUMEN TIP OF DILATOR (PLACED IN STANDARD FASHION THROUGH LUMEN OF INTRODUCER) AFTER MULTIPLE ATTEMPTS AND PRIOR TO ANY CONTACT WITH PATIENT. MULTIPLE ATTEMPTS WERE MADE TO PASS THE GUIDEWIRE WITH BOTH STANDARD/NORMAL PUSHING FORCE AND THEN

  Patient problems: Arrhythmia; Complete Heart Block

  MAUDE report 6224712 ↗

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-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-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-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