Maquet Cardiopulmonary Bypass Tubing Kit Recall: Potential Flow Blockage
Maquet recalls adult cardiopulmonary bypass tubing kits with potential flow blockage risk. Affected units have part number 701056035. Consumers should contact for details.
Use caution until it’s fixed
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Contact the company
What happened, in plain English
Maquet is recalling adult cardiopulmonary bypass tubing kits that may not allow proper blood flow due to a faulty safety valve. This could lead to serious complications during medical procedures. Read more at govinfonow.com/recall/73337-maquet-cardiopulmonary-bypass-tubing-kit-recall-potential-flow-blockage.
Source Summary by GovInfoNow · govinfonow.com/recall/73337-maquet-cardiopulmonary-bypass-tubing-kit-recall-potential-flow-blockage · Updated September 20, 2026 · FDA enforcement record: FDA #Z-2178-2018
Cite this page
“Maquet Cardiopulmonary Bypass Tubing Kit Recall: Potential Flow Blockage.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73337-maquet-cardiopulmonary-bypass-tubing-kit-recall-potential-flow-blockage. Based on FDA recall #Z-2178-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2178-2018%22&limit=1).
Why it’s dangerous
The over-pressure safety valve in the tubing kits might not allow blood to flow properly during surgery. This could cause blood to back up in the patient's system, leading to serious complications.
Who’s affected
Medical professionals using the tubing kits for heart surgeries are most at risk. Patients undergoing cardiopulmonary bypass procedures may be affected if the tubing is used without proper flow.
How to tell if you have this one
Check for the part number 701056035 on the tubing kit. The product is used for adult cardiopulmonary bypass procedures and sold under the Maquet brand.
- Brand
Maquet- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The products were distributed to the following US states: IA and FL.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2178-2018 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.; UDI 0607567204133 | 10 |
| Z-2179-2018 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.; UDI 0607567203600 | 27 |
| Z-2180-2018 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.; UDI 0607567210004 | 8 |
What to do — step by step
Check Product Details
Look for the part number 701056035 on the tubing kit to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Florida and Iowa.
FDA distribution: “The products were distributed to the following US states: IA and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Iowa.
Recall timeline
FDA terminated this recall 2.5 years 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.
Similar recalls
Latest medical device recalls
Keep exploring
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-2178-2018 (July 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2178-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.