Use cautionMedical device recall · FDA · Published November 27, 2018
Medtronic Perfusion Systems Suction Assembly Recall: Y-connector leaks risk blood loss
Medtronic recalls suction and anticoagulation assemblies (BTC93/BTC98) with Y-connectors that may tear or crack, causing leaks and blood loss during use. Affected units have specific serial numbers.
Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.
Take action
Contact the company
📍Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088
“Medtronic Perfusion Systems Suction Assembly Recall: Y-connector leaks risk blood loss.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69427-medtronic-perfusion-systems-suction-assembly-recall-y-connector-leaks-risk. Based on FDA recall #Z-0786-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0786-2019%22&limit=1).
The FDA announced on Nov. 27, 2018, that Medtronic Perfusion Systems is recalling Suction and Anticoagulation assemblies due to potential tearing and cracking of Y-connectors. The agency stated the defect could cause leaks resulting in blood loss or circuit breach.
Distribution: Worldwide, including US, Australia, Canada, France, Germany, Japan, and Sweden
Units affected: 7587
The hazard
Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.
Context
GovInfoNow's records show Medtronic Perfusion Systems has had 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medtronic EOPA Arterial Cannula Recall (June 24, 2026), Medtronic Pediatric Cannula Recall (May 25, 2026), and Medtronic Octopus Evolution AS Tissue Stabilizer Model TS2500 Recall (May 12, 2026). Other recent recalls of similar products include Medline Medical Kits Recall (Feb. 27, 2026), Medline Medical Convenience Kits Recall (Feb. 27, 2026), and Medline Dialysis Kits Recall (Jan. 8, 2026).
How to tell if you have this one
Check for the model numbers BTC93 or BTC98 on the suction assembly. Affected units have specific serial numbers listed in the recall notice, including the lot numbers provided.
Brand
Medtronic Perfusion Systems
Category
Medical device
FDA recall event · 2 products
All 2 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
Ongoing
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.
Recall number
Product, codes & lots
Quantity
Z-0785-2019
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.; BT920: GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180 BT926: GTIN/UDI Lot/Serial Numbers 10673978522477 215782209 10673978522477 215903433 10673978522477 216034158 10673978522477 216107790 10673978522477 216372963 10673978522477 216438301
1100 units
Z-0786-2019
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.; BTC93: GTIN/UDI Lot/Serial Numbers 10673978522545 215691544 10673978522545 215691545 10673978522545 215737228 10673978522545 215737229 10673978522545 215782206 10673978522545 215782207 10673978522545 215816859 10673978522545 215816860 10673978522545 215857423 10673978522545 215857424 10673978522545 215903431 10673978522545 215946277 10673978522545 216245142 10673978522545 215875581 10673978522545 215875582 10673978522545 215875583 10673978522545 216045172 10673978522545 216062720 10673978522545 216107788 10673978522545 216150361 10673978522545 216199988 10673978522545 216238209 10673978522545 216245141 10673978522545 216372965 10673978522545 216372966 10673978522545 216372967 10673978522545 216421235 10673978522545 216421236 10673978522545 216438179 BTC98: GTIN/UDI Lot/Serial Numbers 10673978522576 215782205 10673978522576 215903430 10673978522576 216034160 10673978522576 216062718 10673978522576 216238210
7587 units
Based on the official FDA remedy
What to do — step by step
Check Assembly Model
Identify if your suction assembly has model numbers BTC93 or BTC98.
Contact Medtronic
Reach out to Medtronic Perfusion Systems for guidance on next steps if you have the recalled model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.” 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 published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0786-2019 (November 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0786-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 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.