Sorin S5/C5 Heart-Lung Machine Recalled for Pump Control Failures
Sorin Group is recalling S5/C5 Heart-lung machines and CP5 centrifugal pump systems due to pump speed control knob failures that result in no response.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used during cardiopulmonary bypass where a control failure could lead to harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Sorin Group Deutschland GmbH is initiating a field correction for the S5/C5 Heart-lung machine and CP5 centrifugal pump system. The recall is due to reports of pump speed control knob failures that result in no response. The affected products are intended for use during cardiopulmonary bypass for procedures lasting six hours or less.
The recall involves 323 units. Distribution was worldwide, including the United States (nationwide) and Puerto Rico, as well as internationally to numerous countries including Belgium, Spain, Finland, the United Kingdom, the Netherlands, Sweden, Argentina, Austria, Australia, Canada, Switzerland, China, Costa Rica, Egypt, Hong Kong, Indonesia, Jordan, Japan, South Korea, Kuwait, Lebanon, Libya, Myanmar, Poland, Romania, Serbia, Russia, Singapore, Thailand, Tunisia, Turkey, Taiwan, Ukraine, Vietnam, and South Africa.
Affected item numbers include S5 Item Numbers 10-80-00, 10-85-00, 28-9S-80, and 28-95-8S, and C5 Item Number S8-00-00. Users should contact the recalling firm for further instructions on the field correction.
The recalled product
- Product
- S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
- Manufacturer
- Sorin Group Deutschland GmbH
- Affected units
- 323
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- S5 Item Number: 10-80-00
- 10-85-00
- 28-9S-80
- 28-95-8S. C5 Item Number: S8-00-00
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sorin Group Deutschland GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Sorin Group Deutschland GmbH
See all →- HighSorin CP5 Centrifugal Pump Recalled for Delayed Air Bubble Detection Response
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- HighSorin CP5 Centrifugal Pump System Recalled for Control Knob Failures
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- HighSorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction
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