Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use
Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm medical device with an unevaluated intended use. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High), as the regulatory non-compliance with an unevaluated use presents potential risk despite no reported actual harm.
Plain-English summary
Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter (REF 90338, 0.021 inch by 162 centimeters). The device's Instructions for Use contain an intended use that has not been evaluated by the FDA. Using a device for an unevaluated intended use means it has not undergone FDA review for safety and effectiveness in that specific application.
The affected devices were distributed nationwide across Alabama, Florida, Georgia, Hawaii, Illinois, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Texas, and Virginia. The recall involves nine specific lot numbers: 0000136913, 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, and 0000370674.
Healthcare facilities and physicians using this device should immediately discontinue use of affected units and contact Stryker, Inc. for further instructions. Check the device packaging for the lot number to determine if your unit is affected.
The recalled product
- Product
- Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
- Manufacturer
- Stryker, Inc.
- Category
- Medical Device — Microcatheter
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331
- 0000163582
- 0000164440
- 0000182275
- 0000230955
- 0000240597
- 0000244845
- 0000370674
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Stryker, Inc.
See all →- ModerateStryker Neurovascular Trevo Pro Microcatheter Recalled for Unevaluated Use Statement
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