Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 28, 2020
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Neurovascular recalled Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6M… - a critical-severity action.
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6M… was recalled by Stryker Neurovascular in October 28, 2020. Reason: Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation f…. Check the official notice for the remedy. Verify recall #Z-0114-2021 with the FDA Devices before acting.
The recall
Stryker Neurovascular issued this critical-severity FDA Devices recall-Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation f….
- Critical
- severity level
- 5K units
- affected scope
- Class I
- classification
- October 28, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0114-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0114-2021) was formally reported on October 28, 2020, with the manufacturer initiating the action on September 21, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. Stryker Neurovascular is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as 5365.
The documented reason for this recall is: Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature. Distribution data in the federal record shows the product reached: U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zeala…. 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
5365
Related Recalls
6
3 from same agency
Product description
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002
Reason for recall
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0114-2021 |
| Date reported | October 28, 2020 |
| Date initiated | September 21, 2020 |
| Recalling firm | Stryker Neurovascular |
| Firm location | Fremont, CA |
| Affected scope | 5365 |
| Distribution | U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zealand, Argentina, Eston… |
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-0114-2021) 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? ▼
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002. Recalled by Stryker Neurovascular. Units affected: 5365.
Why was this product recalled? ▼
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Critical. Recall number: Z-0114-2021.
Where was the recalled product distributed? ▼
Distribution: U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zealand, Argentina, Estonia, Lithuania, Slovenia, Australia, Finland, Luxembourg, South Africa, Austria, France, Mexico, South Korea, Belgium, Germany, Netherlands, Spain, Brazil, Greece, Norway, Sweden, Canada, Hong Kong, Philippines, Switzerland, Chile, Hungary, Poland, Taiwan, Colombia, India, Portugal, Thailand, Croatia, Ireland, Romania, Turkey, Czech Republic, Israel, Saudi Arabia, United Arab Emirates, Denmark, Italy, Singapore, United Kingdom, Egypt, Japan, Slovakia, Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0114-2021) 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 October 28, 2020. 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.