Tag: medical_device

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.

Health Politics and Government Medical Science Federal Government FDA Abiomed Oscor Impella Heart Pump Medical Device Product Recall Bleeding Risk Food Recalls Drugs
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…

Health Business Science & Technology Medical Science Federal Government Legal Abiomed FDA 14Fr Low Profile Introducer Kit Thrombus Formation Medical Device Product Recall Patient Safety Food Recalls Drugs
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.

Health Business Medical Science Legal Social Issues KayserBetten IDA pediatric care beds Product Recall Class I Recall Medical Device Child Safety Entrapment Risk Food Recalls FDA Drugs
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.

Health Science & Technology Medical Science Federal Government Legal Asia Q’Apel Medical Inc.072 Aspiration System Hippo Product Recall FDA Medical Device MedWatch

Tag: medical_device

FDA Issues Early Alert for Impella Heart Pump Introducer Kits Over Bleeding Risk

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

FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

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

FDA Alerts Public to Expanded Draeger Anesthesia Machine Correction

Q’Apel Medical Recalls and Discontinues 072 Aspiration System (Hippo)