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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86947

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 17, 2020
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904

Z-0728-2021
Recall number
Z-0728-2021
Initiated
November 17, 2020
Classification
Class I
Status
Terminated
Quantity
219 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729960904. All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution pattern

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.

device · product 2 of 6

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Z-0729-2021
Recall number
Z-0729-2021
Initiated
November 17, 2020
Classification
Class I
Status
Terminated
Quantity
319 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729960911, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution pattern

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.

device · product 3 of 6

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Z-0730-2021
Recall number
Z-0730-2021
Initiated
November 17, 2020
Classification
Class I
Status
Terminated
Quantity
302 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729960928, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution pattern

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.

device · product 4 of 6

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Z-0734-2021
Recall number
Z-0734-2021
Initiated
November 17, 2020
Classification
Class I
Status
Terminated
Quantity
207 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729940814, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution pattern

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.

device · product 5 of 6

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Z-0735-2021
Recall number
Z-0735-2021
Initiated
November 17, 2020
Classification
Class I
Status
Terminated
Quantity
278 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729940821, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution pattern

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.

device · product 6 of 6

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.

Z-0736-2021
Recall number
Z-0736-2021
Initiated
November 17, 2020
Classification
Class I
Status
Terminated
Quantity
386 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729940838, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution pattern

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.