Z-1219-2014Class II

Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X...

Name: Z-1219-2014 Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2014-03-03
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-03-03 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous... on 2014-03-03. FDA classified it as Class II and gives the reason as "During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1219-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Posted: 2014-03-19
Terminated: 2014-08-12
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo sent an Urgent Medical Device Recall letter dated March 3, 2014, to all affected consignees. The letter included the reason for removal, potential hazards, and customer instructions. Terumo CVS advised users to stop using the affected devices and return any unused product on hand. Questions or concerns were directed to Terumo CVS Customer Service: 1-800-521-2818 M-F, 8am-6pm. For questions regarding this recall call 734-741-6173.
Distribution: Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
Product codes and lots: Catalog Number 4934X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1218-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18
Z-1219-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18
Z-1220-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18
Z-1221-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18
Z-1222-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18
Z-1223-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18
Z-1224-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18

Product code DWF

K920902Class IIModification of Sarns Two Stage Venous Cannula3M Health Care, Sarns / cleared 1993-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)