PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported January 1, 2020

Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R

Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI…

Recall #
Z-0730-2020
Affected scope
267,247 units total (262,641 OUS, 4,606 US)
Initiated
November 14, 2019
Compiled from official public sources by the publisher.
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Cardinal Health Inc. recalled Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL a… - a moderate-severity action.

Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL a… was recalled by Cardinal Health Inc. in January 1, 2020. Reason: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information…. Check the official notice for the remedy. Verify recall #Z-0730-2020 with the FDA Devices before acting.

The recall

Cardinal Health Inc. issued this moderate-severity FDA Devices recall-Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information….

Moderate
severity level
267K units
affected scope
Class II
classification
January 1, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0730-2020 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.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
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

Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative t the inner shaft.

Reason for recall

Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".

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 Ongoing
Recall number Z-0730-2020
Date reported January 1, 2020
Date initiated November 14, 2019
Recalling firm Cardinal Health Inc.
Firm location Dublin, OH
Affected scope 267,247 units total (262,641 OUS, 4,606 US)
Distribution Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia,…

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

Scale of Impact

267,247 units total (262,641 OUS, 4,606 US) 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-0730-2020) 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? ▼
Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative t the inner shaft.. Recalled by Cardinal Health Inc.. Units affected: 267,247 units total (262,641 OUS, 4,606 US).
Why was this product recalled? ▼
Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0730-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela..
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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This recall: FDA Devices, reported January 1, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026