CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report

Sarns Malleable Dual-stage Venous Return Cannulae recalled

Terumo Cardiovascular Systems is recalling Sarns Malleable Dual-stage Venous Return Cannulae, 32/ with 1/2" connector, 15" long The, distributed in 15 states. The recall was initiated on 3 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 4935

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1220-2014
FDA event ID: 67598
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2014
FDA classified: 18 Mar 2014
Reported: 26 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Heart & Vascular Devices

Timeline

3 Mar 2014	Recall initiated by company
18 Mar 2014	Classified by FDA	+15 days
26 Mar 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long 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.

Where it was distributed

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.

California Connecticut Florida Georgia Illinois Indiana Louisiana Michigan Minnesota Missouri North Carolina New York Pennsylvania Tennessee Texas

Stores named: CVS

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number 4935

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 67598

Reported	Class	Recall	Company	Reason	Where
26 Mar 2014	CLASS II	Sarns Malleable Dual-stage Venous Return Cannulae recalled	Terumo Cardiovascular Systems	Processing Deviation	15 states
26 Mar 2014	CLASS II	Sarns Malleable Dual-stage Venous Return Cannulae recalled	Terumo Cardiovascular Systems	Processing Deviation	15 states
26 Mar 2014	CLASS II	Sarns Dual-stage Venous Return Cannulae recalled	Terumo Cardiovascular Systems	Processing Deviation	15 states
26 Mar 2014	CLASS II	Sarns Malleable Dual-stage Venous Return Cannulae recalled	Terumo Cardiovascular Systems	Processing Deviation	15 states
26 Mar 2014	CLASS II	Sarns Dual-stage Venous Return Cannulae recalled	Terumo Cardiovascular Systems	Processing Deviation	15 states
26 Mar 2014	CLASS II	Sarns Malleable Dual-stage Venous Return Cannulae recalled	Terumo Cardiovascular Systems	Processing Deviation	15 states

More recalls from Terumo Cardiovascular Systems

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12 Apr 2023Device	CLASS II	Capiox RX15 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
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