Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
USOctopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Recalling Firm: Medtronic Perfusion Systems
Motivo del Retiro / Peligro
TranslatedDuring the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Descripción del Producto e Identificación
TranslatedOctopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Additional Source Details
| Field | Value |
|---|---|
| City | Brooklyn Park |
| State | MN |
| Event id | 98354 |
| Address 1 | 7611 Northland Dr N |
| Address 2 | N/A |
| Code info | UDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 0231758898 0231758932 0231792414 0231792421 0231912903 0232670901 0232709219 0232709254 0232744928 0232784925 0232784989 0232805458 |
| Postal code | 55428-1088 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 939 units |
| Reason for recall | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260113 |
| Initial firm notification | Letter |
| Center classification date | 20260226 |
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 Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1?
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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Resumen
- Empresa ResponsableMedtronic Perfusion Systems
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS Nationwide. Global Distribution.
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🚨 SAFETY ALERT: Medtronic Perfusion Systems - Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 Check if your household is affected: https://therecallfile.com/es/recalls/octopus-nuvo-tissue-stabilizer-disposable-tissue-stabilization-system/FDA-Z-1473-2026
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