Recall archive
14 recalls · page 1 of 1
Reported Nov 2, 2022
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error…
FDA (openFDA device enforcement)
Reported Sep 14, 2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — Certain lots containing undersized dilator.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand · Product · Product details — Potential Endotoxin Contamination
16 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2020
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired…
FDA (openFDA device enforcement)
Reported Jun 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Datascope Corporation
Matched: Brand — There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 16, 2018
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 25, 2018
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2017
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the…
FDA (openFDA device enforcement)
Reported Jun 22, 2016
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
FDA (openFDA device enforcement)
Reported Jun 15, 2016
MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
Matched: Brand — It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath…
FDA (openFDA device enforcement)
Reported Sep 10, 2014
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Datascope Corporation
Matched: Brand — During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
FDA (openFDA device enforcement)
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