Home / Recalls / Edwards Lifesciences, LLC / Z-1705-2019

Z-1705-2019 Class I Terminated

Recalled by Edwards Lifesciences, LLC — Irvine, CA

FDA device recall Z-1705-2019 was initiated by Edwards Lifesciences, LLC on May 14, 2019 and is designated Class I. Reason for recall: Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device … The recall status is terminated (terminated April 23, 2024). Affected quantity: 6552.

Recall Details

Product Type
Devices
Report Date
June 19, 2019
Initiation Date
May 14, 2019
Termination Date
April 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6552

Product Description

IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

Reason for Recall

Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: UT, GA, NJ, CA, OH, PA, AL, FL, TN, TX, ME, MA, IN, MS, NY, VA, MI, IL, CO, OR, WA, SC, AZ, SD, MO, CT, OK, NV, WV, WI, NC, MN, KY; and countries of: United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, France, United Kingdom, Italy, Netherlands, Poland, Romania, and Sweden.

Code Information

All lot numbers.

Other recalls by Edwards Lifesciences, LLC

  • Z-2172-2026 Class II — Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO (March 27, 2026)
  • 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-2083-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-2085-2025 Class I — Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Nu (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-2081-2025 Class I — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula (May 14, 2025)
  • Z-0412-2024 Class II — FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx on (October 4, 2023)
  • Z-0414-2024 Class II — TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (October 4, 2023)
  • Z-0409-2024 Class II — Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, (October 4, 2023)

FDA data resources