Invatec Diver C.E. Aspiration Catheters Recalled for Labeling Issues
Invatec Llc is recalling 177 Diver C.E. aspiration catheters because the labeled indications for use were not included in the existing regulatory clearance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where indications for use were modified without corresponding regulatory clearance. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Invatec Llc is recalling 177 units of the Invatec SpA brand Diver C.E. aspiration catheter, model numbers DVR010014145 and DVR011014145. The product is manufactured by Invatec SpA in Roncadelle, Italy, and distributed by Invatec, Inc. in Bethlehem, PA, and Medtronic Endovascular Therapies in Santa Rosa, CA. The devices were distributed nationwide.
The recall was initiated because the devices were labeled for an intended use that was not included in the existing 510(k) or PMA. Specifically, the indications for use were modified. The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The affected serial numbers are OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, and OPI05684801. Healthcare providers should stop using these devices and contact the recalling firm for further instructions.
The recalled product
- Product
- lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an…
- Manufacturer
- Invatec Llc
- Hazard
- Affected units
- 177
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 (6)
- Serial Numbers/Batches: OPI05931901
- OPI05684401
- OPI05684501
- OPI05684601
- OPI05684701
- OPI05684801
Distribution
Distributed nationwide across the United States.
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