Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks
Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.
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 is classified as FDA Class II and involves a defect in a critical medical device used during surgery. While no injuries or illnesses are reported in the source text, the risk of harm from a leak in a cardiopulmonary bypass circuit is significant, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 256 units of the Cardiovascular Procedure Kit containing a Disposable Centrifugal Pumphead with or without X-Coating. The kits are sterile, single-use devices intended for use only in the extracorporeal circuit for cardiopulmonary bypass procedures. The recall covers specific catalog numbers and pack lot numbers distributed nationwide.
The recall was initiated because leaks were detected on the centrifugal pumphead during the set-up and priming of the bypass circuit. This defect could compromise the integrity of the extracorporeal circuit during surgical procedures.
Healthcare facilities and distributors should stop using the affected kits and contact Terumo Cardiovascular Systems Corporation for instructions on how to return the products. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230,
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 256
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)
- Pack Lot Nos. RA27T
- RA20
- RA06T
- QP09A
- QN18A
- RA06A
- QP16A
- RA20A
- RC03A
- and RC17T. QM21
- RA27
- RA27R
- QN07
- QM28
- QF13A
- QM21
- QN25
- QP16
- QM14
- QN18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation 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.
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