Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 30 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 Hemoconcentrators.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant medical devices.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 30 units of Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE (P/N: 7928-03). The recall is necessary because these kits contain Medivators HPH700 High Performance Hemoconcentrators, which are subject to a separate recall.
The affected kits are customized for specific purchasers and are distributed nationwide, including in California, Connecticut, Florida, and Wisconsin. The specific lot numbers involved are TD02 and TD16.
The FDA has classified this recall as Class II. Users should stop using the affected kits and contact Terumo Cardiovascular Systems Corp for instructions on return or replacement.
The recalled product
- Product
- Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 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…
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 30
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)
- Lot Numbers: TD02
- TD16
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 for Defective Hemoconcentrators
FDA (Devices) · 2015-09-30
Same hazard · component defect
See all →- ModerateMedline EBSI dressing change kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline femoral block trays contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline breast hernia port kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateCenturion dialysis and dressing change kits contain recalled Mastisol adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline EBSI kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
Similar recalls
- ModerateTerumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling
FDA (Devices) · 2016-09-07
- HighTerumo Cardiovascular Procedure Kit Recall for Pumphead Leaks
FDA (Devices) · 2014-07-23
- SevereTerumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve
FDA (Devices) · 2014-01-08
- ModerateTerumo Cardiovascular Procedure Kit Recalled for Incorrect Customer Notification Label
FDA (Devices) · 2014-04-23
- ModerateTerumo Recalls Custom Cardiovascular Procedure Kits and Safety Valves
FDA (Devices) · 2015-07-01
- HighTerumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect
FDA (Devices) · 2014-11-12