Adelante SafeSheath Ultra Lite ASUP071318PRecalls & reported problems
Oscor Inc. · Peel-Away Introducer with Hemostatic Valve, 7F · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885672104891), received between Nov 4, 2024 and Nov 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K073100); 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.
Reports received per month
Most reported problems
Device problems
- Material Too Rigid or Stiff1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE VALVE DOES NOT BREAK WHEN USING THE PEEL-OFF SLEEVE. WE HAVE TO CUT THE VALVE MANUALLY. TWO MEDICAL DEVICES HAVE BEEN RECEIVED. SEE IMAGES IN ATTACHMENT BELOW. CLARIFICATION OF EVENTS: (B)(4): THE VALVE DOES NOT BREAK WHEN USING THE PEEL-AWAY SHEATH. WE HAVE TO MANUALLY CUT THE VALVE. PATIENT NO AFFECTED. NO CONSEQUENCES OR IMPACTS TO PATIENT. INCIDENT DATE: ON (B)(6) 2024 (B)(4): SILICONE VALVE ON THE PEEL AWAY WOULD NOT BREAK AND HAD TO BE CUT WITH SCISSORS OR SCALPEL. PATIENT NOT AFFECTED. INCIDENT DATE: ON (B)(6) 2024. THIS COMPLAINT IS ASSOCIATED W/(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20604520 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K073100. One submission often covers many models, so check the product and lot details in each record.
- Z-0055-2012 · Aug 1, 2011 · Terminated8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedu
- Z-0130-2009 · Jul 3, 2008 · TerminatedOscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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