Medtronic Harmony Delivery Catheter System
Medtronic Heart Valves Division
The hazard
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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Medtronic Harmony Delivery Catheter System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model GTIN 00763000341367Model Lot Numbers: 0012508285Model 0012517045Model 0012526102Model 0012526103Model 0012614786Model 0012614787Model 0012623740Model 0012623741Model 0012642959Model 0012659419Model 0012663878Model 0012663879Model 0012690218Model 0012699635Model 0012702022Model 0012710787Model 0012728367Model 0012728369Model 0012777713Model 0012804152Model 0012804579Model 0012824770Model 0012824771Model 0012874526UPC 00763000341367UPC 00763000544027UPC 00763000520151UPC 00763000582951UPC 00763000918712Would you have heard about this one?
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