Home / Recalls / Edwards Lifesciences, LLC / Z-0238-2024

Z-0238-2024 Class II Ongoing

Recalled by Edwards Lifesciences, LLC — Irvine, CA

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
September 7, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
185

Product Description

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Reason for Recall

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Distribution Pattern

OUS: Singapore, Taiwan, Canada

Code Information

UDI-DI: 00690103043532, Lot: 64936927

Other recalls by Edwards Lifesciences, LLC

  • Z-2081-2025 Class I — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula (May 14, 2025)
  • Z-2085-2025 Class I — Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Nu (May 14, 2025)
  • Z-2083-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-2080-2025 Class I — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula (May 14, 2025)
  • Z-2084-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-2082-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-0411-2024 Class II — FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx on (October 4, 2023)
  • Z-0413-2024 Class II — TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (October 4, 2023)
  • Z-0410-2024 Class II — Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. (October 4, 2023)
  • Z-0409-2024 Class II — Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, (October 4, 2023)