Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
USAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Recalling Firm: Abiomed, Inc.
Motif du rappel / Danger
TranslatedPotential for thrombus formation during prolonged use of the introducer.
Description du produit & Identification
TranslatedAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 99002 |
| Address 1 | 22 Cherry Hill Dr |
| Address 2 | N/A |
| Code info | Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530. |
| Postal code | 01923-2575 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 7 units |
| Reason for recall | Potential for thrombus formation during prolonged use of the introducer. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Aperçu
- Entreprise responsableAbiomed, Inc.
- StatusOngoing
- Niveau de risqueClass I
- DistributionWorldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
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🚨 SAFETY ALERT: Abiomed, Inc. - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. Check if your household is affected: https://therecallfile.com/fr/recalls/abiomed-impella-cp-set-with-smartassist-10th-generation-containing-aff/FDA-Z-2602-2026
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