Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare — Class II medical device recall Z-2104-2014

Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-07-30, distributed nationwide. During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose f

Recall number	`Z-2104-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States
Recall initiated	2014-05-23
Classified	2014-07-22
Reported by FDA	2014-07-30
Terminated	2015-02-24
Distributed	Nationwide (US)
Countries outside the US	AE, AU, BE, CA, CL, GB, JP, MX, MY, SG, TH, TW
Quantity	2,290 units
Reason classes	specification failure
Lot numbers	`0645280`, `0649157`, `0654734`, `0666686`, `0674810`, `0678724`, `0682221`, `0684790`, `0689843`, `0698319`, `0698323`, `0698910`, `646450`
Model numbers	`816460`, `820731`, `820732`

Product

Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Reason for recall

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

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-2104-2014. 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.