Terumo Sarns Centrifugal Pump Recalled for Housing Cracks and Leaks
Terumo is recalling Sarns Centrifugal Pumps because cracks in the housing can cause fluid leaks during cardiac procedures. No patient injuries have been reported.
What this means for you
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 where a defect (leaks) poses a risk of harm, but the source explicitly states that no patient injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Centrifugal Pump, a single-use medical device used in cardiovascular procedures. The recall was initiated after complaints indicated that the disposable pump heads exhibited leaks during the priming of the bypass circuit and during cardiopulmonary bypass (CPB) procedures.
The company's investigation identified that cracks in the Top Housing and Magnet Back Housing of the pump cause the housing to become compromised, allowing fluid to leak from the pump head. The source text explicitly states that in each of the reported incidents, there were no reports of patient injury as a result of these leaks.
The recall affects 579 units that have entered the distribution chain. Terumo has identified 33 domestic consignees and 0 international consignees affected by this recall. The devices are sold single sterile in cartons of 8 units or provided in bulk, non-sterile for inclusion in Cardiovascular Procedure Kits.
The recalled product
- Product
- The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Pr
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 579
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 (2)
- TAOS
- TC03
Distribution
Distribution scope not specified by the agency.
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