Browse Device Recalls

67 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 67 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 67 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 6, 2026	Battery Charging Station; Model: 0998-00-0802;	The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP ...	Class III	Datascope Corp.
Jan 23, 2026	CS100 IABP. Software Version CS100 IABP Q.01.	The firm has identified that the battery runtime and cycle specifications contained in the device...	Class II	Datascope Corp.
Jan 23, 2026	CS300 IABP. Software Version CS300 IABP C.01.	The firm has identified that the battery runtime and cycle specifications contained in the device...	Class II	Datascope Corp.
Nov 4, 2025	Cardiosave Hybrid. Intra-Aortic Balloon Pump system.	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce...	Class II	Datascope Corp.
Nov 4, 2025	Cardiosave Rescue. Intra-Aortic Balloon Pump system.	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce...	Class II	Datascope Corp.
Oct 23, 2025	Cardiosave Hybrid	The IFU addendum updates the Vibration and Shock Table to reference the correct standards.	Class III	Datascope Corp.
Oct 23, 2025	Cardiosave Rescue	The IFU addendum updates the Vibration and Shock Table to reference the correct standards.	Class III	Datascope Corp.
Sep 17, 2024	MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-...	There is discrepant labeling on the inner and outer packaging of the device.	Class II	Datascope Corp.
Aug 8, 2024	CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ...	Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p...	Class I	Datascope Corp.
Aug 8, 2024	CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ...	Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p...	Class I	Datascope Corp.
Aug 8, 2024	CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ...	Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl...	Class I	Datascope Corp.
Aug 8, 2024	CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ...	Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ...	Class II	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were identifying autofill failure conditions on the devices causing pump stops.	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ...	Class II	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were identifying autofill failure conditions on the devices causing pump stops.	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting that the device was not charging as expected. It was discovered that users w...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ...	Class I	Datascope Corp.
Jul 31, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080...	Users were reporting that the device was not charging as expected. It was discovered that users w...	Class I	Datascope Corp.
Jun 23, 2023	SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 23, 2023	LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov...	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o...	Class II	Datascope Corp.
Jun 5, 2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power...	Class I	Datascope Corp.
Jun 5, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power...	Class I	Datascope Corp.
Jun 5, 2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru...	Class I	Datascope Corp.
Jun 5, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0...	IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru...	Class I	Datascope Corp.
May 4, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080...	The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc...	Class III	Datascope Corp.
Apr 4, 2023	MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32	The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompati...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) ...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 28, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbe...	There is an issue related to the Safety Disk not meeting a performance requirement that may impac...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c...	An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-08...	An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c...	An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	There have been reported failures of the high pressure helium regulator, which may cause a helium...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-080...	An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P...	Class I	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue. Model Number: 0998-00-0800-83.	Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick ...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, ...	Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick ...	Class II	Datascope Corp.
Feb 7, 2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	There have been reported failures of the high pressure helium regulator, which may cause a helium...	Class II	Datascope Corp.
Dec 19, 2022	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080...	The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ...	Class I	Datascope Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.