Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 21, 2015
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
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. I…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corporation recalled Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; … - a critical-severity action.
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; … was recalled by Boston Scientific Corporation in January 21, 2015. Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion…. Check the official notice for the remedy. Verify recall #Z-0915-2015 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this critical-severity FDA Devices recall-Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion….
- Critical
- severity level
- 278 units
- affected scope
- Class I
- classification
- January 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0915-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0915-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on November 19, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Los Gatos, CA. Federal records list the affected scope as 278 units, all sizes.
The documented reason for this recall is: 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 emb… Distribution data in the federal record shows the product reached: Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
278 units, all sizes
Related Recalls
6
3 from same agency
Product description
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0915-2015 |
| Date reported | January 21, 2015 |
| Date initiated | November 19, 2014 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Los Gatos, CA |
| Affected scope | 278 units, all sizes |
| Distribution | Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0915-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.. Recalled by Boston Scientific Corporation. Units affected: 278 units, all sizes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2015. Severity: Critical. Recall number: Z-0915-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0915-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 21, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.