Sorin FlexFlow Venous Cannula Recall: Sharper Tip Risk
Sorin Group recalls FlexFlow Venous Cannula Model 200-200 due to sharper tip than expected. This may cause injury during medical procedures. Affected units have specific lot numbers.
Use caution until it’s fixed
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Contact the company
What happened, in plain English
Sorin Group recalls a specific lot of FlexFlow Venous Cannula Model 200-200 because it is sharper than expected. This could increase the risk of injury during medical procedures. Patients using this device should contact the manufacturer for details. Read more at govinfonow.com/recall/72940-sorin-flexflow-venous-cannula-recall-sharper-tip-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72940-sorin-flexflow-venous-cannula-recall-sharper-tip-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0076-2018
Cite this page
“Sorin FlexFlow Venous Cannula Recall: Sharper Tip Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72940-sorin-flexflow-venous-cannula-recall-sharper-tip-risk. Based on FDA recall #Z-0076-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0076-2018%22&limit=1).
Why it’s dangerous
The recalled cannula has a sharper tip than expected, which could cause injury during insertion or use in medical procedures. This sharpness may lead to tissue damage or other complications if not handled carefully.
Who’s affected
Healthcare professionals using the FlexFlow Venous Cannula Model 200-200 for medical procedures are most at risk. Patients receiving this device during surgery may also be affected.
How to tell if you have this one
Check for the model number 200-200 on the device. The specific lot number 181185 is associated with this recall. The device comes in a sterile, sealed pouch with a unique identifier.
- Brand
Sorin Group- Category
Medical device
What to do — step by step
Check Device Lot Number
Look for the lot number 181185 on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (nationwide) Internationally to France and Spain” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device safe to use?
The recall indicates the device may be sharper than expected, so it is not recommended for use until the manufacturer provides a remedy.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0076-2018 (September 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0076-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.