CLASS II Device recall · Reported 9 Aug 2017 · FDA Enforcement Report
Stroke Fast Pack(TM) Trevo XP ProVue Retriever recalled
Stryker Neurovascular is recalling Stroke Fast Pack(TM) Trevo XP ProVue Retriever , Trevo Pro 18 Microcatheter, AXS Catalyst, distributed nationwide in the US. The recall was initiated on 26 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2801-2017
- FDA event ID
- 77671
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2017
- FDA classified
- 29 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 26 Jun 2017 | Recall initiated by company | |
| 29 Jul 2017 | Classified by FDA | +33 days |
| 9 Aug 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
Product as listed by the FDA
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
Where it was distributed
nationwide
Questions about this recall
Is Stroke Fast Pack(TM) Trevo XP ProVue Retriever , Trevo Pro 18 Microcatheter, AXS Catalyst recalled?
Yes. Stryker Neurovascular recalled Stroke Fast Pack(TM) Trevo XP ProVue Retriever , Trevo Pro 18 Microcatheter, AXS Catalyst on 26 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2801-2017.
Why was it recalled?
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
Which lots are affected?
Lot Numbers: QPC40107530, QPC40107745, QPC40107814, QPC40110247
Where was it sold?
nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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