Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 28, 2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system f…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Edwards Lifesciences, LLC recalled Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) … - a critical-severity action.
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) … was recalled by Edwards Lifesciences, LLC in August 28, 2019. Reason: The action has been initiated to address reports of burst balloons which have resulted in significant difficu…. Check the official notice for the remedy. Verify recall #Z-2225-2019 with the FDA Devices before acting.
The recall
Edwards Lifesciences, LLC issued this critical-severity FDA Devices recall-The action has been initiated to address reports of burst balloons which have resulted in significant difficu….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- August 28, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2225-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2225-2019) was formally reported on August 28, 2019, with the manufacturer initiating the action on July 9, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Edwards Lifesciences, LLC is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 2208.
The documented reason for this recall is: The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures Distribution data in the federal record shows the product reached: US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria. 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
2208
Related Recalls
6
3 from same agency
Product description
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Reason for recall
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2225-2019 |
| Date reported | August 28, 2019 |
| Date initiated | July 9, 2019 |
| Recalling firm | Edwards Lifesciences, LLC |
| Firm location | Irvine, CA |
| Affected scope | 2208 |
| Distribution | US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria |
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-2225-2019) 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? ▼
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246. Recalled by Edwards Lifesciences, LLC. Units affected: 2208.
Why was this product recalled? ▼
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Critical. Recall number: Z-2225-2019.
Where was the recalled product distributed? ▼
Distribution: US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2225-2019) 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 August 28, 2019. 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.