FDAClass I · Medical device · Recall Z-2687-2026 · Recalled July 22, 2026
ABIOMED Impella 5 recall — Abiomed, Inc.
Agency report date: July 22, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class I: most serious — reasonable probability of serious health consequences or death.
Affected product: ABIOMED Impella 5 recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More Abiomed recalls
- Impella Optical Controller recall — Abiomed, Inc.FDA · September 23, 2026
- Impella Optical Controller with the below product descriptions and corresponding Product C recall — Abiomed, Inc.FDA · September 23, 2026
- Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.FDA · September 23, 2026
- ABIOMED Intro Kit recall — Abiomed, Inc.FDA · July 22, 2026
- ABIOMED Insertion Kit recall — Abiomed, Inc.FDA · July 22, 2026
Other medical device recalls from around the same time
- MEDLINE convenience kits labeled as recall — Medline Industries, LPFDA · July 29, 2026
- MEDLINE ANTERIOR HIP recall — Medline Industries, LPFDA · July 29, 2026
- Bone Marrow Tray recall — Argon Medical Devices, IncFDA · July 22, 2026
- Arterial Line Kit 20ga x 6 recall — Argon Medical Devices, IncFDA · July 22, 2026
- T-Lok Bone Marrow Tray recall — Argon Medical Devices, IncFDA · July 22, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 20, 2026 at 6:00 PM UTC.