Tag: medical_device

FDA Issues Early Alert for Draeger VentStar Resus Neo Hoses Due to Cracks

3 Sep 2026 4:11 p.m. · Source: US Food and Drug Administration

Draeger's VentStar Resus Neo hoses are subject to an FDA Early Alert due to reported cracks. This issue could lead to serious patient harm, including death, if used. No injuries or deaths have been reported as of August 27.

Health Business Science & Technology Medical Science Legal Federal Government Draeger VentStar Resus Neo Breathing Circuit Medical Device FDA Product Recall Patient Safety Food Recalls Drugs
FDA Classifies GE HealthCare Monitoring Software Issue as Class II Recall

3 Sep 2026 1:28 p.m. · Source: US Food and Drug Administration

The FDA has reclassified an early alert for GE HealthCare's Portrait Core Services Software as a Class II Recall. The issue, identified during a service update, has not led to patient monitoring disruptions.

Health Science & Technology Politics and Government Medical Science Computers and Internet Federal Government Legal GE HealthCare FDA Portrait Core Services Software Medical Device Product Recall Class II Recall Patient Monitoring Food Recalls Drugs
Medtronic Issues Early Alert for Bravo CF Capsule Delivery Devices Over Serious Injury Risks

27 Aug 2026 11:20 a.m. · Source: US Food and Drug Administration

Medtronic and Given Imaging issued an Early Alert for Bravo CF capsule delivery devices, citing risks of attachment/detachment failure. This issue has led to 184 serious injuries, prompting a recommendation for device removal due to deployment control problems.

Health Business Medical Science Legal Federal Government Medtronic Given Imaging Bravo CF capsule Medical Device Product Recall Esophagus FDA Food Recalls Drugs
FDA Issues Class I Recall for Boston Scientific ENROUTE Catheters

26 Aug 2026 11:16 a.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's ENROUTE Transcarotid Neuroprotection System and Plus, citing potential for serious injury or death. This urgent action requires removal of affected percutaneous catheters from use.

Health Business Politics and Government Medical Science Federal Government Legal Product Recall Medical Device Boston Scientific FDA ENROUTE Transcarotid Neuroprotection System Class I Recall Percutaneous Catheter Food Recalls Drugs
FDA Issues Early Alert for NOxBOX Nitric Oxide Delivery Systems Over Oxygen Leak Risks

24 Aug 2026 12:51 p.m. · Source: US Food and Drug Administration

The FDA issued an "Early Alert" for NOxBOX nitric oxide delivery systems due to oxygen leaks. These leaks could cause increased nitric oxide dosage or therapy interruption, posing risks like methemoglobinemia and oxygen desaturation, especially for neonates.

Health Politics and Government Business Medical Science Federal Government Social Issues FDA NOxBOX Nitric Oxide Delivery System Medical Device Oxygen Leaks Methemoglobinemia Neonates Food Recalls Drugs
FDA Issues Early Alert for CooperSurgical Neonatal Ventilators Due to Connection Issue

24 Aug 2026 12:39 p.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding specific CooperSurgical neonatal CPAP ventilators. A loose connection could lead to loss of pressure, affecting patient oxygenation. CooperSurgical recommends removal of affected units; no serious injuries reported.

Health Business Science & Technology Medical Science Federal Government Social Issues FDA CooperSurgical Medical Device Ventilator Neonatal CPAP Product Recall Patient Safety Food Recalls Drugs
FDA Issues Early Alert for GE HealthCare Software Issue

21 Aug 2026 4:07 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert regarding GE HealthCare's Portrait Core Services software. An update issue may cause patient discharge from monitoring and reset alarm settings, potentially leading to loss of monitoring or alarms. No serious injuries or deaths…

Health Science & Technology Business Medical Science Computers and Internet Federal Government FDA GE HealthCare Portrait Core Services Medical Device Software Issue Patient Monitoring Early Alert Food Recalls Drugs
FDA Issues Early Alert for Boston Scientific ENROUTE System Recall

24 Jul 2026 3:44 p.m. · Source: US Food and Drug Administration

Boston Scientific is recalling specific lots of its ENROUTE Transcarotid Neuroprotection System and System Plus due to arterial sheath tip separation, which can lead to serious complications like stroke. The FDA has issued an Early Alert.

Health Business Science & Technology Medical Science Federal Government Boston Scientific ENROUTE Medical Device Product Recall Neuroprotection System Tip Separation FDA Food Recalls Drugs
Bolton Medical Issues Class I Recall for Relay Pro Thoracic Stent Graft System

17 Jul 2026 12:23 p.m. · Source: US Food and Drug Administration

Bolton Medical has initiated a Class I recall for its Relay Pro Thoracic Stent Graft System (N4: Non-Bare Stent Configuration 32mm and above) due to a critical issue where the graft may fail to unclasp, potentially leading to patient death…

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FDA Issues Early Alert for Resmed Ventilators Over Leakage Risk

15 Jul 2026 6:33 p.m. · Source: US Food and Drug Administration

The FDA issued an Early Alert for Resmed Astral 100 and 150 ventilators due to supercapacitor leakage, potentially causing therapy discontinuation. Five serious injuries are reported. Patients should not stop using devices without clinician instruction, as this issue could lead…

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FDA Issues Class I Recall for Medtronic Harmony Delivery Catheter System

13 Jul 2026 3:19 p.m. · Source: US Food and Drug Administration

Medtronic's Harmony Delivery Catheter System faces a Class I recall by the FDA due to a risk of distal tip detachment. This serious issue could require secondary intervention and poses significant patient risks, though no serious injuries or deaths are…

Health Business Politics and Government Medical Science Federal Government Legal Medtronic Harmony Delivery Catheter System Product Recall FDA Medical Device Class I Recall Pulmonary Valve Food Recalls Drugs
FDA Issues Class I Recall for Abiomed Impella Heart Pump Controllers

22 Jun 2026 11:24 a.m. · Source: US Food and Drug Administration

The FDA has upgraded an alert for Abiomed's Automated Impella Controllers to a Class I recall, the most serious type, following two injuries and one death. The recall focuses on updated usage instructions to prevent serious harm, not device removal.

Health Business Law Enforcement Medical Science Legal Social Issues FDA Abiomed Automated Impella Controllers Class I recall Heart pump Medical device Product Recall Food Recalls Drugs
FDA Issues Early Alert for Impella Heart Pump Introducer Kits Over Bleeding Risk

18 Jun 2026 4:34 p.m. · Source: US Food and Drug Administration

The FDA issued an Early Alert for Abiomed and Oscor's Introducer Kits used with Impella heart pumps due to potential leakage. Manufacturing issues increase access-site bleeding risk, prompting a recommendation for corrections before continued use to prevent serious complications.

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FDA Issues Early Alert on Insulet Omnipod Insulin Pump Under-Delivery Risk

4 Jun 2026 3:31 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert concerning Insulet Omnipod insulin pumps. Certain Pods may have a cannula tear, leading to insulin under-delivery. Affected models include Omnipod 5, DASH, and Eros, prompting a customer removal recommendation.

Health Business Science & Technology Medical Science Federal Government Insulet Omnipod Insulin Pump FDA Medical Device Product Recall Insulin Under-delivery Food Recalls Drugs
FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

2 Jun 2026 6:13 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Abiomed's 14Fr Low Profile Introducer Kits due to a high rate of complaints regarding thrombus formation. This issue has led to three serious injuries, prompting Abiomed to recommend removal of all affected…

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KayserBetten Issues Urgent Correction for IDA Pediatric Care Beds Amid Serious Injury Risk

30 May 2026 7:07 a.m. · Source: US Food and Drug Administration

KayserBetten is correcting its IDA pediatric care beds due to a serious entrapment risk, identified as a Class I recall. A free hand control replacement with automatic locking will be provided to prevent injury or death.

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FDA Alerts Public to Expanded Draeger Anesthesia Machine Correction

18 May 2026 12:51 p.m. · Source: US Food and Drug Administration

Draeger, Inc. has expanded a correction for Atlan A350 and A350 XL anesthesia machines due to a manufacturing error causing ventilator failure. The FDA alert highlights risks including hypoxia and cardiac arrest, urging immediate correction.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues Draeger Inc.Atlan A350 Atlan A350 XL Anesthesia Machine Ventilator Failure Medical Device Product Recall Food Recalls FDA Drugs
Q’Apel Medical Recalls and Discontinues 072 Aspiration System (Hippo)

24 Apr 2025 10:23 a.m. · Source: US Food and Drug Administration

Q’Apel Medical Inc. recalls 1,617 units of its 072 Aspiration System (Hippo) due to concerns about the distal tip design. The company has chosen to discontinue the product line.

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