Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.
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 medical device component (hemoconcentrator) used in high-risk cardiovascular procedures. While the source text does not explicitly report injuries or illnesses, the use of a recalled component in a critical care setting represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 32 units of the Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak (P/N: 73124). These kits are customized for specific purchasers and contain a variety of legally marketed medical devices, including the Medivators HPH700 High Performance Hemoconcentrator.
The recall is being conducted because the kits contain the recalled Medivators HPH700 High Performance Hemoconcentrator component. The HPH700 is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.
The affected kits were distributed nationwide, including in California, Connecticut, Florida, and Wisconsin. The specific lot numbers involved are TD02, TD02A, TD23, and TD23A. Healthcare providers and purchasers should stop using these kits and contact Terumo Cardiovascular Systems Corp for further instructions.
The recalled product
- Product
- Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 32
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)
- Lot Numbers: TD02
- TD02A
- TD23
- TD23A
Distribution
Part of a larger recall action
This product is one of 7 recalled by Terumo Cardiovascular Systems Corp 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 7 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corp
See all →- ModerateTerumo Cardiovascular Procedure Kit Recall for Shipping Damage
FDA (Devices) · 2022-04-27
- ModerateTerumo Tubing Pack Convenience Kit Recalled for Incorrect Expiration Date
FDA (Devices) · 2018-08-01
- SevereTerumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks
FDA (Devices) · 2018-04-18
- ModerateTerumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling
FDA (Devices) · 2016-09-07
- HighTerumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
FDA (Devices) · 2015-09-30
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- SevereExactech AcuMatch XLE Hip Implant Liner Recall
FDA (Devices) · 2025-02-19
- ModerateMedline Medical Convenience Kits Recall Due to Recalled Component
FDA (Devices) · 2024-12-11