Quick Facts at a Glance
- Recall Date
- June 11, 2026
- Hazard Level
- HIGH
- Brand
- Abiomed
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abiomed
- Model numbers
- Pump Set Code 0052-0039, Introducer Product Code 0052-3053. GTIN: 00813502011715, 00813502012736. All current batches in field.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 11, 2026
Reported by FDA DEVICE
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories. Reason: 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.. Classification: Class I. Quantity: 1,223 units. Distribution: Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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