Medtronic Harmony Delivery Catheter System
USMedtronic Harmony Delivery Catheter System
Recalling Firm: Medtronic Heart Valves Division
Reason for Recall / Hazard
TranslatedDevices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Product Description & Identification
TranslatedMedtronic Harmony Delivery Catheter System
Additional Source Details
| Field | Value |
|---|---|
| City | Santa Ana |
| State | CA |
| Event id | 99031 |
| Address 1 | 1851 E Deere Ave |
| Address 2 | N/A |
| Code info | GTIN 00763000341367, Lot Numbers: 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824770, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965210, 0012965211, 0012976400, 0012986693, 0013063766, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624, 0013236643, 0013272796, 0013272798. GTIN 00763000544027, Lot Numbers: 0012508285, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663879, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965211, 0012976400, 0012986693, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624. GTIN 00763000520151, Lot Numbers: 0012575897, 0012642965, 0012728368, 0013272... [TRUNCATED] |
| Postal code | 92705-5720 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 1881 units |
| Reason for recall | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260702 |
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 Medtronic Harmony Delivery Catheter System?
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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Overview
- Recalling FirmMedtronic Heart Valves Division
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
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🚨 SAFETY ALERT: Medtronic Heart Valves Division - Medtronic Harmony Delivery Catheter System Check if your household is affected: https://therecallfile.com/recalls/medtronic-harmony-delivery-catheter-system/FDA-Z-2624-2026
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