CLASS I ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report
ClotTriever XL Catheter recalled by Inari Medical - Oak Canyon
Inari Medical - Oak Canyon is recalling ClotTriever XL Catheter, distributed nationwide in the US. The recall was initiated on 19 Jul 2024 and the FDA has classified it as Class I.
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-2587-2024
- FDA event ID
- 95069
- Recalling firm
- Inari Medical - Oak Canyon, Irvine, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 19 Jul 2024
- FDA classified
- 21 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 19 Jul 2024 | Recall initiated by company | |
| 21 Aug 2024 | Classified by FDA | +33 days |
| 28 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
Product as listed by the FDA
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Where it was distributed
Worldwide - US Nationwide distribution including in the states of PA, FL, GA, CA, IL, SC, NY, MN, UT, TN, WI, MI, KS, SD, AZ, AR, IN, KY, TX, AL, MS, DE, MA, OH, MO, WV, VA, NC, NV, CO, NE, OR, NM, NH, NJ, CT, ID, IA, WA, MD, OK, RI, DC, PR, LA, ND, VT and the countries of New Zealand, Chile, Australia.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
Which lots are affected?
UDI-DI:00850291007277. All lots. IU-01011 REV. C.
Where was it sold?
Worldwide - US Nationwide distribution including in the states of PA, FL, GA, CA, IL, SC, NY, MN, UT, TN, WI, MI, KS, SD, AZ, AR, IN, KY, TX, AL, MS, DE, MA, OH, MO, WV, VA, NC, NV, CO, NE, OR, NM, NH, NJ, CT, ID, IA, WA, MD, OK, RI, DC, PR, LA, ND, VT and the countries of New Zealand, Chile, Australia.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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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