Avid Medical, Inc.: Cardiac Catheterization Kit
Cardiac Catheterization Kit Recall Summary AVID Medical is recalling Halyard STANDARD LINE INSERTION PACK cardiac catheterization kits (Model PVHM234-01) distributed nationwide because the silicone seal may not seal properly, potentially causing the seal to dome and leading to fluid leakage or blockage. This is a Class II recall affecting patients who received these kits during cardiac procedures. The affected kits were distributed across all U.S. states and Washington, D.C.
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
- Reason
- Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the state of California.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3a8344bf-8acd-4a0b-8941-7bfed4cd042e