Z-0736-2021Class I

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile...

Name: Z-0736-2021 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile...
Creator: Boston Scientific Corporation
Published: 2020-11-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-11-17 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in... on 2020-11-17. FDA classified it as Class I and gives the reason as "Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0736-2021
Classification: Class I
Status: Terminated
Initiated: 2020-11-17
Posted: 2021-01-09
Terminated: 2022-01-24
Recalling firm: Boston Scientific Corporation
Product: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Reason for recall: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued a press release on 11/17/2020, as well as letters dated 11/17/2020 issued via overnight mail delivery to the U.S. direct account medical facilities and clinical investigators. OUS customers were also issued the letter on 11/17/2020 through various methods, including email, courier, hand-delivery, and phone. The letter was flagged "Medical Device Recall-Immediate Action Required" and said BSC was conducting a removal of the unused inventory and there was no safety issue for patients who previously received the valve. The letter explained the details surrounding the reason for removal from the field. Regarding actions to be taken by the customer, BSC recommended that patients who have the device continue with their routine follow-up care and no additional action is needed for them. Further distribution or use of the remaining product was to be ceased immediately. The product was to be immediately segregated and returned to Boston Scientific per their enclosed instructions. If the customer was a distributor, they were instructed to forward the notification to their customers as the recall was to the hospital level. A Reply Verification Tracking Form was enclosed to be completed and returned via email or FAX even if the customer no longer has any of the devices.
Quantity in commerce: 386 devices
Distribution: Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.
Product codes and lots: GTIN 08714729940838, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09
Z-0729-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09
Z-0730-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09
Z-0734-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09
Z-0735-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09
Z-0736-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)