SUCTION / ANTICOAGULATION ASSEMBLY — Class II medical device recall Z-0786-2019
Ongoing recall by Medtronic Perfusion Systems, reported 2019-02-06, distributed nationwide. Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracki
| Recall number | Z-0786-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2018-11-27 |
| Classified | 2019-01-29 |
| Reported by FDA | 2019-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, FR, JP, SE |
| Quantity | 7,587 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10673978522545, 10673978522576 |
| Serial numbers | 10673978522545, 10673978522576, 215691544, 215691545, 215737228, 215737229, 215782205, 215782206, 215782207, 215816859, 215816860, 215857423, 215857424, 215875581, 215875582, 215875583, 215903430, 215903431, 215946277, 216034160, 216045172, 216062718, 216062720, 216107788, 216150361 and 12 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0786-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.