Lotus TAVR 23mm recall
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23…
Why was Lotus TAVR 23mm recalled?
Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers: 14113043, 14118011, 14118012, 14119047, 14119048, 14119049, 14119050, 14119051, 14120027, 14120028, 14120029, 14120030, 14120031, 14121035, 14121036, 14121037, 14121038, 14121039, 14121040, 14121041, 14125040, 14125041, 14125042, 14125043, 14125044, 14125045, 14125046, 14125047, 14125048, 14125049, 14127073, 14127077, 14127078, 14127079, 14127080, 14127081, 14127082, 14127083, 14127084, 14127085, 14127086, 14141044, 14141045, 14141046, 14141047, 14141048, 14141049, 14141050, 14141051, 14141052, 14141053, 14148034, 14148035, 14148036, 14148037, 14148039, 14153054, 14153055, 14153057, 14153058, 14153059, 14153075, 14153076, 14153077, 14153078, 14153079, 14157003, 14157015, 14157016, 14157017, 14157019, 14157020, 14157021, 14157022, 14157023, 14178024, 14178025, 14178026, 14178027, 14178028. Nov. 15, 2014 to Jan. 24, 2015.
- Product
- Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 278 units, all sizes
- Distribution
- Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
- Recall date
- January 21, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)