Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall. Class I is defined in the severity rubric as meeting Severe criteria (score 4). Although no reported illnesses or injuries are mentioned in the source text, the agency's own classification dictates the severity level.
Plain-English summary
Medtronic Heart Valves Division is recalling the Harmony Delivery Catheter System in specific manufacturing lots worldwide. Devices in these lots contain inner shaft assemblies with a manufacturing issue that may increase the potential for the distal tip to detach from the delivery system under certain procedural or anatomical conditions.
The affected units were distributed worldwide, including throughout the United States and internationally to 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, and the United Kingdom. A total of 1881 units are involved in this recall.
Healthcare providers and patients who have received or are scheduled to receive this device should contact Medtronic for information about the affected lot numbers and appropriate next steps. Patients with questions about their specific device should consult their healthcare provider.
The recalled product
- Product
- Medtronic Harmony Delivery Catheter System
- Manufacturer
- Medtronic Heart Valves Division
- Hazard
- device-detachment
- procedural-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00763000341367
- Lot Numbers: 0012508285
- 0012517045
- 0012526102
- 0012526103
- 0012614786
- 0012614787
- 0012623740
- 0012623741
- 0012642959
- 0012659419
- 0012663878
- 0012663879
- 0012690218
- 0012699635
- 0012702022
- 0012710787
- 0012728367
- 0012728369
- 0012777713
Distribution
Distributed nationwide across the United States.
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