Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
USAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Recalling Firm: Oscor Inc.
Motif du rappel / Danger
TranslatedDue to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Description du produit & Identification
TranslatedAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Produits concernés
TranslatedAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Additional Source Details
| Field | Value |
|---|---|
| City | Palm Harbor |
| State | FL |
| Event id | 99102 |
| Address 1 | 4875 Palm Harbor Blvd |
| Code info | All Lots within Expiry/GTIN:00885672009793, 00813502010664 |
| Postal code | 34683-1217 |
| Report date | 20260722 |
| Product type | Devices |
| Product quantity | 355 units |
| Reason for recall | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260610 |
| Center classification date | 20260710 |
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 REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F...?
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 responsableOscor Inc.
- StatusOngoing
- Niveau de risqueClass I
- DistributionDistribution in the US state of MA
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🚨 SAFETY ALERT: Oscor Inc. - Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories. Check if your household is affected: https://therecallfile.com/fr/recalls/abiomed-ref-0052-3025-introducer-kit-for-impella-hemostatic-peel-away/FDA-Z-2678-2026
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