MEDLINE ECVC8355 (UDI 10653160378914)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653160378914), received between Dec 12, 2024 and Sep 22, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

47 other recalls cover devices cleared under the same FDA submission (K213481); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Material Deformation

  It was reported that CVICU received the patient from the CVOR and noticed on the chest x-ray the AVA HF was kinked internally.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857611 ↗
• InjuryFeb 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2025 "THE CENTRAL LINE/INTRODUCER WAS BEING INSERTED INTO THE PATIENT, THE WIRE WAS REMOVED FROM THE DILATOR AFTER THE INSERTION, THE PROVIDER ASPIRATED FROM ALL THREE PORTS WHEN THEY EXPERIENCED THE ISSUE".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21432270 ↗
• InjuryJan 2, 2025Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE CUSTOMER, THE PATIENT'S "AVA HF" LINE WAS SHOWN TO BE "KINKED INTERNALLY" WHEN AN X RAY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055328 ↗
• MalfunctionDec 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  LINE BEGAN TO "CRUMPLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213481. One submission often covers many models, so check the product and lot details in each record.

• Z-3267-2026 · Aug 10, 2026 · Open, Classified
  Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number:
• Z-3229-2026 · Aug 10, 2026 · Open, Classified
  Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
• Z-3209-2026 · Jul 31, 2026 · Open, Classified
  Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
• Z-3137-2026 · Jul 23, 2026 · Open, Classified
  Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
• Z-3070-2026 · Jul 20, 2026 · Open, Classified
  Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER
• Z-3024-2026 · Jul 10, 2026 · Open, Classified
  Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ
• Z-2995-2026 · Jul 8, 2026 · Open, Classified
  Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU
• Z-3054-2026 · Jun 12, 2026 · Open, Classified
  Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Numb
• Z-2736-2026 · Jun 10, 2026 · Open, Classified
  Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
• Z-2764-2026 · Jun 8, 2026 · Open, Classified
  MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
• Z-2748-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
• Z-2749-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
• Z-2747-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
• Z-2611-2026 · May 28, 2026 · Open, Classified
  Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
• Z-2697-2026 · May 28, 2026 · Open, Classified
  Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B;

…and 32 more.