ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism
Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall with potential for serious adverse events including pulmonary embolism and device entrapment. Per FDA classification guidelines, Class I recalls require a minimum severity score of 4. No deaths or injuries have been reported in the source.
Plain-English summary
Inari Medical is updating instructions for the ClotTriever XL Catheter (30 mm, REF 41-102), a component of the ClotTriever Thrombectomy System. The recall affects approximately 2,488 units distributed worldwide, including across all U.S. states and several international locations. All lot numbers are included.
The catheter instructions are being updated to prevent potential adverse events that could occur if the catheter bag becomes overloaded with thrombus material or if the catheter is improperly positioned—either pulled through the internal jugular vein access site or not adequately withdrawn from the heart. These complications may result in device entrapment, pulmonary embolism, or the need for surgical intervention.
Healthcare providers and facilities using this device should obtain and review the updated instructions (IU-01011 REV. C) for proper catheter handling, positioning, and removal. Patients who have received treatment with this device should consult their healthcare provider if they experience symptoms suggestive of vascular complications.
The recalled product
- Product
- ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
- Manufacturer
- Inari Medical - Oak Canyon
- Affected units
- 2,488
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 (1)
- UDI-DI:00850291007277. All lots. IU-01011 REV. C.
Distribution
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