ModerateClass IITerminated

FDA Devices recall · Reported February 20, 2019

Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system an

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 20, 2019. Severity: Moderate. Recall number: Z-0835-2019.

Q: Where was the recalled product distributed?

Distribution: WorldwideDistribution.

Q: 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.

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Recall #: Z-0835-2019
Affected scope: 159,448 units
Initiated: January 22, 2019

Compiled from official public sources by the publisher. · Updated September 2026

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Edwards Lifesciences, LLC recalled Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS… - a moderate-severity action.

Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS… was recalled by Edwards Lifesciences, LLC in February 20, 2019. Reason: This action has been initiated to address complaint reports received for crimp balloon and inflation balloon …. Check the official notice for the remedy. Verify recall #Z-0835-2019 with the FDA Devices before acting.

The recall

Edwards Lifesciences, LLC issued this moderate-severity FDA Devices recall-This action has been initiated to address complaint reports received for crimp balloon and inflation balloon ….

Moderate
severity level: 159K units
affected scope: Class II
classification: February 20, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0835-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis

Reason for recall

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0835-2019
Date reported	February 20, 2019
Date initiated	January 22, 2019
Recalling firm	Edwards Lifesciences, LLC
Firm location	Draper, UT
Affected scope	159,448 units
Distribution	WorldwideDistribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

159,448 units units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0835-2019) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

Why was this product recalled? ▼

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 20, 2019. Severity: Moderate. Recall number: Z-0835-2019.

Where was the recalled product distributed? ▼

Distribution: WorldwideDistribution.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 20, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026