Sorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction
Sorin Group is recalling 84 S5 Heart-Lung Machines because of a malfunction in the cardioplegia control system.
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 medical device used during critical cardiac surgery. While the agency classification is Class II, the source text does not report any injuries or illnesses, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sorin Group Deutschland GmbH is recalling 84 units of the S5 Heart-lung machine, also known as the Stockert S5 System. The affected devices are identified by catalogue numbers 48-30/40/50-00 and specific serial numbers listed in the recall documentation. These systems are intended for use during cardiopulmonary bypass for procedures lasting six hours or less.
The recall is being conducted due to a malfunction of the cardioplegia control. The source text does not specify the exact nature of the malfunction or any reported injuries or illnesses associated with the defect.
The affected units were distributed worldwide, including in the United States (specifically Washington, New York, Virginia, Tennessee, South Carolina, Texas, California, Colorado, Massachusetts, Wisconsin, Maryland, Alabama, North Dakota, and Puerto Rico) and internationally to Italy, Finland, Germany, Sweden, and Great Britain. Users of these devices should contact Sorin Group for instructions on how to proceed.
The recalled product
- Product
- S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
- Manufacturer
- Sorin Group Deutschland GmbH
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 84
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 (20)
- Serial Numbers: 48E00235
- 48E00339
- 48E00342
- 48E01753
- 48E02767
- 48E02753
- 48E02745
- 48E02746
- 48E02748
- 48E02416
- 48E01033
- 480E1038
- 48E01040
- 48E01041
- 48E01043
- 48E01044
- 48E01051
- 48E02631
- 48E01183
- 48E02758
Distribution
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