Datascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect
Datascope Corporation is recalling eight Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.
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 high-risk medical device used in life-support procedures where a valve failure could cause serious harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Datascope Corporation is recalling eight units of the Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01. The recall is due to a potential defect where the over-pressure safety (OPS) valve in the tubing kits may not allow flow through.
The affected products were distributed to the states of Iowa and Florida. The device is a sterile, non-pyrogenic, single-use system used for extracorporeal support during cardiopulmonary bypass procedures.
Users should stop using the affected tubing kits and contact Datascope Corporation for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product…
- Manufacturer
- Datascope Corporation
- Affected units
- 8
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 (1)
- UDI 0607567210004
Distribution
Part of a larger recall action
This product is one of 3 recalled by Datascope 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Datascope Corporation
See all →- HighLINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling
FDA (Devices) · 2022-11-02
- HighMEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
FDA (Devices) · 2022-09-14
- HighUndersized Dilator in Balloon Catheter Insertion Kit Recalled
FDA (Devices) · 2022-09-14
- HighFDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect
FDA (Devices) · 2022-09-14
- HighDatascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2020-09-02
Same hazard · valve failure
See all →- HighAbbott Navitor Titan Heart Valve Recall: Manufacturing Defect
FDA (Devices) · 2024-11-27
- HighAbbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect
FDA (Devices) · 2024-11-27
- HighAbbott Navitor Heart Valve Recalled for Leaflet Deflection Manufacturing Defect
FDA (Devices) · 2024-11-27
- HighAspira Pleural Drainage Catheter trays recalled for valve failure
FDA (Devices) · 2023-06-21
- HighFDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure
FDA (Devices) · 2023-06-21
Similar recalls
- LowDatascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits
FDA (Devices) · 2018-06-13
- LowDatascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure
FDA (Devices) · 2018-06-13
- HighDatascope Recalls Custom Tubing Kits Due to Seal Separation Risk
FDA (Devices) · 2018-05-16
- SevereMaquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
FDA (Devices) · 2019-06-05
- SevereDatascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
FDA (Devices) · 2018-05-16
- SevereDatascope recalls custom tubing kits with potential Better Bladder seal defect
FDA (Devices) · 2018-05-16