Z-2602-2026 Class I Ongoing
FDA device recall Z-2602-2026 was initiated by Abiomed, Inc. on May 22, 2026 and is designated Class I. Reason for recall: Potential for thrombus formation during prolonged use of the introducer. The recall status is ongoing. Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Reason for Recall
Potential for thrombus formation during prolonged use of the introducer.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Code Information
Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.