Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 23, 2014
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalled Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreig… - a critical-severity action.
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreig… was recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular in April 23, 2014. Reason: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.. Check the official notice for the remedy. Verify recall #Z-1454-2014 with the FDA Devices before acting.
The recall
Micro Therapeutics Inc, Dba Ev3 Neurovascular issued this critical-severity FDA Devices recall-Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire..
- Critical
- severity level
- 567 units
- affected scope
- Class I
- classification
- April 23, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1454-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1454-2014) was formally reported on April 23, 2014, with the manufacturer initiating the action on April 1, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Micro Therapeutics Inc, Dba Ev3 Neurovascular is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 567 units total (323 units in US).
The documented reason for this recall is: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, …. 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
567 units total (323 units in US)
Related Recalls
6
3 from same agency
Product description
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Reason for recall
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1454-2014 |
| Date reported | April 23, 2014 |
| Date initiated | April 1, 2014 |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Firm location | Irvine, CA |
| Affected scope | 567 units total (323 units in US) |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Port… |
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-1454-2014) 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? ▼
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.. Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular. Units affected: 567 units total (323 units in US).
Why was this product recalled? ▼
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Critical. Recall number: Z-1454-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1454-2014) 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 April 23, 2014. 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.