CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

Terumo Advanced Perfusion System 1 Roller Pump recalled

Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System 1 Roller Pump, distributed nationwide in the US. The recall was initiated on 10 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00886799000533; Serial Numbers: 7919 8165 8166 8167 8168 8169 8170 8173 8174 8175 8176 8179 8180 8181 8182 8183 8184 8185 8186 8187 8188 8189 8190 8191 8192 8193 8194 8195 8196 8197 8198 8199 8200 8201 8202 8203 8204 8205 8206 8207 8208 8209 8210 8211 8212 8213 8214 8215 8216 8217 8218 8219 8220 8221 8222 8223 8224 8225 8226 8227 8228 8229 8230 8231 8232 8233 8234 8235 8236 8237 8241 8242 8243 8244 8251 8253 8254 8255 8256 8257 8258 8259 8260 8261 8262 8263 8264 8265 8266 8267 8268 8269 8270 8271 8273 8274 8275 8276 8280 8307 8308 8309 8310 8311 8313 8335

Quantity recalled106

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-1109-2020
FDA event ID: 84663
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2020
FDA classified: 7 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

10 Jan 2020	Recall initiated by company
7 Feb 2020	Classified by FDA	+28 days
19 Feb 2020	Published in enforcement report	+12 days

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

Reason for recall

These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.

Nationwide Connecticut Florida Louisiana Massachusetts Michigan New York Texas

Questions about this recall

Is Terumo Advanced Perfusion System 1 Roller Pump recalled?

Yes. Terumo Cardiovascular Systems recalled Terumo Advanced Perfusion System 1 Roller Pump on 10 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1109-2020.

Why was it recalled?

Which lots are affected?

UDI: 00886799000533; Serial Numbers: 7919 8165 8166 8167 8168 8169 8170 8173 8174 8175 8176 8179 8180 8181 8182 8183 8184 8185 8186 8187 8188 8189 8190 8191 8192 8193 8194 8195 8196 8197 8198 8199 8200 8201 8202 8203 8204 8205 8206 8207 8208 8209 8210 8211 8212 8213 8214 8215 8216 8217 8218 8219 8220 8221 8222 8223 8224 8225 8226 8227 8228 8229 8230 8231 8232 8233 8234 8235 8236 8237 8241 8242 8243 8244 8251 8253 8254 8255 8256 8257 8258 8259 8260 8261 8262 8263 8264 8265 8266 8267 8268 8269 8270 8271 8273 8274 8275 8276 8280 8307 8308 8309 8310 8311 8313 8335

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.

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

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